Medicines: Medicine
These cover the regulation of medicines around the licensing, manufacturing, wholesale distribution, advertising, sale and supply of medicines to ensure that medicines are safe, of acceptable quality and effective. The Government is currently undertaking a project to consolidate and review UK medicines legislation. The aim is to bring together over 200 statutory instruments into one set of regulations that are simpler and clearer. Additionally, this project will identify where changes are needed to the current regulations to ensure the legislation is fit for purpose. We want to encourage ideas and stimulate discussions from business, patients and the public and all those affected by our regulations to help improve medicines regulation, without compromising safety.
We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system; that increases choice and opportunity, and maintains necessary safeguards and legal protections. For example, where medicines regulation relates to the activity of healthcare professionals is there scope for achieving objectives in different ways, by looking at the respective roles of medicines legislation and professional regulation in safeguarding the public?
You can find the regulations that relate to Medicines to the left below.
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Medicines (Licensing of Intra-Uterine Contraceptive Devices) (Miscellaneous Amendments) Regulations 1978, SI 1978/1140 Amends the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 and the Medicines (Labelling) Regulations 1976 so as to make them apply to intra-uterine contraceptive devices as they apply to medicinal products. Read More… (opens in a new window)
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Medicines (Breathing Gases) Order 1977, SI 1977/1488 Amends the Medicines Act 1968 specifying certain circumstances when the Act does not apply to gases for human use. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 SI 1971/972 Amends the standard provisions for product licences, clinical trial certificates, manufacturer’s licences and wholesale dealer’s licences relating to relevant medicinal products. This also includes product licences of right, for blood products and immunological medicinal products for human use; manufacture’s licences and manufacture’s licences of right for vaccines, toxins and sera; and product licences of right for certain medicinal products. Read More… (opens in a new window)
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Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992, SI 1992/2845 Amends the Medicines Regulations 1977 to prescribe additional conditions to the undertakings given by or on behalf of manufacturers of imported medicinal products in connection with an application for the grant of a product licence; and exclude applications relating to products imported from another member State of the EEC. Read More… (opens in a new window)
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Medicines (Retail Pharmacists–Exemptions from Licensing Requirements) Order 1971, SI 1971/1445 Exemptions in the Medicines Act 1968 for pharmacists who prepare medicines are amended as follows: Stocks prepared can only be sold by the pharmacy that prepared them; Pharmacists do not need a product licence for such medicines, provided they do not advertise them; and retail pharmacists are also not required to hold a manufacturer’s or wholesale dealer’s licence. Read More… (opens in a new window)
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Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005, SI 2005/2789 This instrument is one of a number of statutory instruments which implement European Directive 2004/27/EC which relates to manufacturing and wholesale dealing. Read More… (opens in a new window)
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Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971, SI 1971/974 Describes how applications for manufacturer’s and wholesale dealer’s licences are to be made and the information required. Read More… (opens in a new window)
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Medicines (Application for Manufacturer’s and Wholesale Dealer’s Licences) Amendment Regulations 1983, SI 1983/1725 Amends the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 so that the particulars required are included for every application for the grant of a wholesale dealer’s licence relating to a proprietary medicinal product and to a ready-made veterinary drug, (as similarly defined) where the product is imported other than from a member of the European Community. Read More… (opens in a new window)
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Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Amendment Regulations 1993, SI 1993/832 Amends the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 to include new requirements for applicants for wholesale dealer’s licences which relate to medicinal products. These include: providing the name and address of a responsible person; details of an emergency plan to be instituted where products are recalled; and arrangements for keeping records. Read More… (opens in a new window)
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Medicines (British Pharmacopoeia Commission) Amendment Order 1982, SI 1982/1335 Amends the Medicines (British Pharmacopoeia Commission) Order 1970 to allow the preparation a compendium, and future editions of this compendium, containing information relating to substances and articles which are or may be used in the practice of veterinary medicine, veterinary surgery or in manufacture of those veterinary items. Read More… (opens in a new window)
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Medicines (British Pharmacopoeia Commission) Order 1970, SI 1970/1256 This Order establishes a committee to be known as the British Pharmacopœia Commission for the purpose of preparing future editions of the British Pharmacopœia and any amendments, and of preparing lists of names suitable for use as headings for monographs appearing in the British Pharmacopœia. Read More… (opens in a new window)
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Medicines (Certificates of Analysis) Regulations 1977, SI 1977/1399 The Medicines (Certificates of Analysis) Regulations 1976 are revoked. The format of certificates of analysis required by the Medicines Act are set out and the fee set. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Wholesale Dealing) Order 1990, SI 1990/566 Revokes provisions of the Medicines (Exemption from licenses) (Wholesale Dealing) Order 1989. Exempts the wholesale of a medicinal product by the product license holder or assembler where the product remains on the premises of a licensed manufacturer or assembler. Read More… (opens in a new window)
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Medicines (Specified Articles and Substances) Order 1976, SI 1976/968 Extends the Medicines Act 1968 to include contact lenses, associated substances and intra-uterine contraceptive devices. It modifies part of the Act in relation to these. Read More… (opens in a new window)
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Medicines (Termination of Transitional Exemptions) (No 3) Order 1975, SI 1975/761 Updates the Medicines (Termination of Transition Exemptions (No 1) Order 1972 to appoint 1st September 1972 as the day for ending the transnational exemptions in relation to ingredients that are medicinal products. Read More… (opens in a new window)
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Medicines (Contact Lens Fluids and Other Substances) (Labelling) Regulations 1979, SI 1979/1759 Specifies the information to be provided on the package labels or leaflets of substances used with contact lenses or blanks. Read More… (opens in a new window)
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Medicines (Contact Lens Fluids and Other Substances) (Termination of Transitional Exemptions) Order 1981, SI 1981/1690 Appoints 1st July 1983 as the day when the regulation ceases to have effect relating to fluids and substances used in contact lenses or blanks. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Assembly) Order 1979, SI 1979/1114 Exempts certain medicines from labelling restrictions relating to the absence of an issued marketing authorisation and sets out the requirements for this. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Importation) Order 1984, SI 1984/673 Specifies exemptions for the import and sale or supply of medicines without a marketing authorisation if the medicines are for use by a health professional. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Wholesale Dealing in Confectionery) Order 1975, SI 1975/762 Exempts from the restrictions in the Medicines Act 1968 relating to wholesale dealing in medicinal products except in accordance with a licence granted under the Act, the sale or offer for sale by way of wholesale dealing of medicinal products which are for sale as confectionery where certain conditions apply. Read More… (opens in a new window)
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Medicines Act 1968 (Amendment) Regulations 1993, SI 1993/834 Amends the Medicines Act 1968 to cover products for human use which had previously not been within the scope of the regulations including; immunological products, medicinal products based on human blood, blood constituents or radioactive isotopes (other than isotopes which are sealed sources). Read More… (opens in a new window)
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Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Amendment Regulations 1977, SI 1977/1052 Provides the requirements of those who act as qualified persons to be named in applications for manufacturer’s licences relating to medicinal products and in applications for wholesale dealer’s licences relating to imported proprietary medicinal products. Read More… (opens in a new window)
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Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977, SI 1977/1038 Prescribes the conditions to be incorporated in undertakings given by or on behalf of overseas manufacturers of imported medicinal products, where applicants are required to do so by the licensing authority. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1983, SI 1983/1730 Sets out the requirements for applications to the licensing authority to renew licences that have been granted concerning medicinal products including product licences, manufacturers licences, and wholesale dealers licences. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Food and Cosmetics) Order 1971, SI 1971/1410 Part of the medicines consolidation and exempts medicines from restrictions included in the Medicines Act 1968 when they are taken as foods or used as cosmetics. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment (No 2) Regulations 1993, SI 1993/2539 States additional requirements to be incorporated into standard provisions for product licences relating to medicinal products. They include provisions on medicinal product for human use. Read More… (opens in a new window)
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Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, SI 1994/3144 Provides that the functions of a member state should be undertaken in the UK by the licensing authority. Also sets out provisions on marketing authorisations by the European Commission or the licensing authority. Read More… (opens in a new window)
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Medicines (Codification Amendments Etc) Regulations 2002, SI 2002/236 Amends references in the Medicines Act 1968, and various statutory instruments relating to medicinal products and devices, following adoption of Directive 2011/83/EC on medicinal products for human use. Read More… (opens in a new window)
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Medicines (Extension to Antimicrobial Substances) Order 1973, SI 1973/367 Extends certain specified provisions of the Medicines Act 1968 concerning the holding of licences, the provision of information, the commission of offences, the prohibition of sale, supply or importation and the promotion of sales to the classes of substances set out in this Order. Read More… (opens in a new window)
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Medicines (Applications for Grant of Product Licences–Products for Human Use) Regulations 1993, SI 1993/2538 Sets out requirements laid down by the European Medicine Directives relating to applications for marketing authorisations for medicines and replace the requirements of the Medicines (Application for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971. Read More… (opens in a new window)
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Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971 Amends the provisions for applications for Product Licences and Clinical Trial and Animal Test Certificates. Specifically, they set out the form and manner of applications, information contained in or accompanying an application and any supplementary provisions. Read More… (opens in a new window)
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Medicines (Marketing Authorisations Etc) Amendment Regulations 2005, SI 2005/2759 Amends the regulations which implement the EU legislation relating to marketing authorisations for medicinal products for human use. It implements the provisions relating to the grant, suspension and revocation of authorisations and the obligations of authorisation holders. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment (No 2) Regulations 1977, SI 1977/1039 The Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 are amended adding requirements for imported medicines and product licences of right which have been renewed. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment (No 2) Regulations 1992, SI 1992/3272 Requires the submission of samples of certain medicinal products to the licensing authority but don’t apply to blood and certain immunological products for human use which have been examined by the regulatory authority of another member state and comply with the necessary EC directives. Read More… (opens in a new window)
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Medicines (Importation of Medicinal Products for Re-exportation) Amendment Order 1977, SI 1977/640 Amends the Medicines (Importation of Medicinal Products for Re-exportation) Order by adding to the cases to which the exemption from the requirement to hold a product licence applies. Read More… (opens in a new window)
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Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992, SI 1992/755 Partially implements three European Directives. Special conditions are required for applications for product licences for medicines that are immunological products, radiopharmaceuticals and those derived from human blood or plasma. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Emergency Importation) Order 1974, SI 1974/316 Exempts from the restriction in the Medicines Act 1968 where the importation of medicinal products is not allowed except in line with a product licence and importation of that product becomes necessary under certain conditions stated in the regulation. Read More… (opens in a new window)
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Medicines (Contact Lens Fluids and Other Substances) (Exemption from Licences) Amendment Order 1979, SI 1979/1745 This Order amends the Medicines (Contact Lens Fluids and Other Substances) (Exemption from Licences) Order 1979 in order to remove a possible ambiguity in the reference to “contact lens”. Read More… (opens in a new window)
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Medicines (Surgical Materials) Order 1971, SI 1971/1267 This order extends to certain surgical materials whose materials or substances are not medicinal products but are used partially or wholly for medicinal purpose. Read More… (opens in a new window)
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Medicines (Contact Lens Fluids and Other Substances) (Exemption from Licences) Order 1979, SI 1979/1585 This Order exempts certain healthcare professionals from having to comply with labelling restrictions on certain substances and fluids for use with contact lenses or blanks. Read More… (opens in a new window)
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Medicines (Dental Filling Substances) Order 1975, SI 1975/533 Involves the provisions for the issuing of marketing authorisations, sale and supply, import, provision of information (and offences related to these areas) concerning dental filling substances Read More… (opens in a new window)
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Medicines (Contact Lens Fluids and Other Substances) (Labelling) Amendment Regulations 1981, SI 1981/1689 Amends the temporary and transitional provisions of the Medicines Regulations 1979 in relation to persons transitionally exempted under the Medicines Act 1968 from holding a product or manufacturer’s licence, and in relation to wholesalers and retailers. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972, SI 1972/1200 Provides exemption from restrictions in the Medicines Act 1968 relating to certain activities concerned with medicinal products including obtaining the manufacture of stocks of certain medicinal products by practitioners and pharmacists without the need of a product licence. Read More… (opens in a new window)
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Medicines (Importation of Medicinal Products for Re-exportation) Order 1971, SI 1971/1326 Provides exemption from the prohibition to import medicinal products except in accordance with a product licence and only takes effect where the medicinal products, articles and substances are to be re-exported without any change in their form or their manner of assembly. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemptions) Order 1980, SI 1980/1924 Consolidates and amends provisions granting exemption from the restrictions imposed by the Medicines Act 1968. Sets certain specific conditions that must be fulfiled by a registered pharmacy in relation to medicinal products not on a general sale list sold or supplied only on premises of a registered pharmacy. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment (No 2) Order 1999, SI 1999/2535 Specifies which products can be sold or supplied without the supervision of a pharmacist (the general sale list). Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Order 1997, SI 1997/1830 Specifies the descriptions and classes of prescription only medicines. These are medicinal products which, subject to exemptions, may only be sold or supplied on a retail basis in accordance with a prescription given by an appropriate practitioner (for example, a doctor) and which may be administered only by or in accordance with the directions of such a practitioner. Many medicinal products are included in a class of such medicines by reason of the substances contained in them (see Schedule 1) but others are included because of other criteria, such as their method of administration. Read More… (opens in a new window)
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Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 SI 2008/1692 Allows medicinal products, apart from certain medicines classed as controlled drugs, to be sold or supplied in the UK, in accordance with a prescription given by a doctor or dentist in another EEA State or Switzerland. Read More… (opens in a new window)
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Medicines for Human Use (Prescribing) Order 2005, SI 2005/765 Amends the Prescription Only Medicines (Human Use) Order 1997 to extend supplementary prescribing to podiatrists, physiotherapists and radiographers and allow prescribing of unlicensed medicinal products under supplementary prescribing arrangements. The Order also amends the range of medicines which can be sold, supplied or administered by registered ophthalmic opticians. Furthermore, it extends the list of medicines which can be prescribed by Extended Formulary Nurse Prescribers and introduces the use of electronic signatures on prescriptions. Read More… (opens in a new window)
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Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006, SI 2006/2807 Amends the Medicines for Human Use regulations in relation to the sale and supply of prescription medicines. Amendments relate to conditions of use for veterinary medicinal products, operators working in radioactive medical procedures, chiropodists and podiatrists, and moutain rescue first aiders. Read More… (opens in a new window)
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Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007, SI 2007/2178 Impacts upon the sale or supply of prescription medicines: The Order allows independent hospitals, clinics and medical agencies and pharmacists working under arrangement with these bodies) to sell medicines in accordance with a Patient Group Direction (PGD) The Order also extends the use of PGDs in the private sector in Northern Ireland. Read More… (opens in a new window)
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Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2005, SI 2005/768 Amends the Medicines for Human Use regulations to include a definition of “supplementary prescriber” (certain health professionals including nurses, pharmacists and midwives). Also sets out exemptions. Read More… (opens in a new window)
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Medicines for Human Use (Miscellaneous Amendments) (No 2) Regulations 2009, SI 2009/3063 Impacts upon the sale or supply of mediciones for human use regulations and marketing authorisations regulations. Make amendments to the individuals who can order unlicensed medicines (e.g. Nurses), and obtain wholesale suppliers of specified prescription medicines (e.g. dispensing opticians). Read More… (opens in a new window)
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Medicines for Human Use (Miscellaneous Amendments) Order 2010, SI 2010/1136 These regulations impact upon the sale and supply of prescription medicines by allowing dental hygienists and therapists to supply or administer prescription medicines under patient group directions and expanding and updating the range of prescription medicines that may be supplied or administered by registered midwives. Read More… (opens in a new window)
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Medicines for Human Use (Prescribing) (Miscellaneous Amendments) (No 2) Order 2005, SI 2005/3324 Extends the list of medicines which can be prescribed by Extended Formulary Nurse Prescribers. It also adds a further medicine to the list of medicines for which optometrists can sell, supply or write an order for additional supply. Read More… (opens in a new window)
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Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005, SI 2005/1507 Impacts upon the sale and supply of prescription medicines, and contain miscellaneous measures relating to registered optometrists, Naloxine, and Water for Injection. Read More… (opens in a new window)
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Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006, SI 2006/915 Amend the Medicines for Human Use regulations to remove the Nurse Prescribers’ Extended Formulary (NPEF) and the title “Extended Formulary Nurse Prescriber”. They also set out measures relating to Nurse Independent Prescribers and Pharmacist Independent Prescribers. Read More… (opens in a new window)
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Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008, SI 2008/1161 Introduces independent prescribing by optometrists and enable hospitals and health centres to sell, offer for sale or supply medicines in accordance with the written directions of an optometrist independent prescriber. Read More… (opens in a new window)
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Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2009, SI 2009/1165 Allows pharmacists to supply a prescription medicine for up to thirty days treatment (unless the medication contains a controlled drug) at the request of a dentist and contains provisions for sale and supply of prescription only medicines by a pharmacist in the event of a pandemic disease. Read More… (opens in a new window)
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Medicines (Collection and Delivery Arrangements–Exemption) Order 1978, SI 1978/1421 Provides exemption from the restrictions imposed by the Medicines Act 1968 where medicines for human use are supplied at premises which are not a registered pharmacy and such medicines have been dispensed in accordance with a prescription as part of certain collection and delivery arrangements. Read More… (opens in a new window)
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Medicines (Exemptions and Miscellaneous Amendments) Order 2009, SI 2009/3062 Relates to creation of new exemptions from restrictions in dealing with medicinal products for manufacture and wholesale dealing; and other measures relating to HM armed forces and registered dispensing opticians. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980, SI 1980/1923 Consolidates previous legislation. Contain restrictions on whom can be sold wholesale supplies of medicines; and also contain measures relating to enforcement of the Medicines Act, record keeping by pharmacists and limits on the pack sizes of certain medicines. Read More… (opens in a new window)
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Medicines (Exemption from Licensing) (Radiopharmaceuticals) Order 1992, SI 1992/2844 Exempts from the restrictions imposed by the Medicines Act 1968 for the preparation of certain radiopharmaceutical products for human use where the radiopharmaceutical product is prepared at the time of its administration and is not in breach of the Medicines (Administration of Radioactive Substances) Regulations 1978. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 2000, SI 2000/1918 Amends the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 by inserting a reference to additional classes of person to whom prescription only medicines and pharmacy medicines may be sold by way of wholesale dealing. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1992, SI 1992/2938 Adds National Health Service Trusts, Health and Social Services and the Common Services Agency to the classes of persons who may be sold prescription only medicines and pharmacy medicines by way of wholesale dealing. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005, SI 2005/1520 Implements certain provisions of EEC Directive 2001/83/EC relating to wholesale dealing, supply of unlicensed medicines and the definition of ‘supplementary prescribers’. Adds optometrists and includes other healthcare professionals to the definition of ‘supplementary prescriber’. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) (Amendment) Order 1997, SI 1997/1350 Amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 (S.I. 1980/1924) by specifying exemptions for the control to the sale and supply of a homoeopathic veterinary medicinal product. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment (No 2) Order 1998, SI 1998/2368 Amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 by allowing certain human homoeopathic products to be exempt from the control to their sale or supply. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment (No 2) Order 2004, SI 2004/1190 Amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 by adding registered dietitians, occupational therapists, orthotists, prosthetists and language and speech therapists to the list of those that who can supply medicinal products under a Patient Group Direction. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment Order 1982, SI 1982/27 Amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 by extending the range of products which may be sold or supplied by state registered chiropodists. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment Order 1994, SI 1994/2409 Amends the Medicines (Pharmacy and General Sale— Exemption) Order 1980 by granting a temporary exemption, up to two years, subject to conditions, to certain Homoeopathic medicines for human use. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment Order 1998, SI 1998/107 Amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 by extending the range of products which may be sold or supplied by state registered chiropodists, with the appropriate certificate of competence, to include ibuprofen, co-dydramol 10/500, amorolfine hydrochloride and topical hydrocortisone. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment Order 2000, SI 2000/1919 Amends the Medicines (Pharmacy and General Sale – Exemption) Order 1980 by providing exemptions for the supply of a medicine under a Patient Group Direction. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment Order 2003, SI 2003/697 Amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 by allowing certain non-NHS providers e.g. independent hospital, clinic or agency, nursing home, prison services or the armed forces to supply a medicine under a Patient Group Direction. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment Order 2004, SI 2004/1 Amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 by allowing the sale or supply of medicines of a hospital or health centre under the written directions of a supplementary prescriber or an independent nurse prescriber. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale–Exemption) Amendment Order 2005, SI 2005/766 Amends the definition of “supplementary prescriber” to include chiropodists and podiatrists, physiotherapists and diagnostic or therapeutic radiographers, allows for the supply of general sale medicines by a prison officer, and changes the list of medicines which may be sold or supplied by a registered ophthalmic optician. Read More… (opens in a new window)
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Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989, SI 1989/1852 Amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 (the POM Order) and the Medicines (Pharmacy and General Sale—Exemption) Order 1980 (the Pharmacy and General Sale Exemption Order by providing exemption for a qualified first-aid personnel on “offshore installations” such as oil rigs. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment (No 2) Order 2000, SI 2000/2526 The GSL Order (1984) is amended by adding famotidine tablets at a maximum strength of 10mg for the short-term relief of heartburn or indigestion, alpha-pinene for external use only and heparinoid at a maximum strength of 1.0% for treating bruises and sprains in adults and children over 6. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1985, SI 1985/1540 Specifies the medicinal products which can be sold or supplied without the supervision of a pharmacist, and products which can be sold from automatic machines and amends the list the substances that can be included in products for general sale. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1987, SI 1987/910 Amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 by changing certain entries in Schedule 1 of the original Order and excludes from general sale preparations of Aloxiprin or aspirin promoted, recommended or marketed wholly or mainly for administration to children. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1989, SI 1989/969 Amends GSL Order (1984) on entries for benzalkonium chloride and turpentine oil; and deletes entry for Danthron. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1990, SI 1990/1129 Amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984, which specifies the medicinal products which can be sold or supplied without the supervision of a pharmacist and products which can be sold from automatic machines, by inserting and amending certain entries on Liquid Paraffin and Povidone-Iodine. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1992, SI 1992/1535 Amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984, which specifies the medicinal products which can be sold or supplied without the supervision of a pharmacist, by deleting the entries on Noscapine and Noscapine Hydrochloride in Schedule 1 of the Order. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1994, SI 1994/2410 Amends Schedule 1 of the GSL Order, which lists the substances that can be included in products for general sale, by adding several substances, changing a number of previous entries and adding a definition of the term “effervescent”. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1995, SI 1995/3216 Amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 which specifies the medicinal products which can be sold or supplied without the supervision of a pharmacist by inserting new entries and changing other entries on the list of substances that can be included in products for general sale. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1997, SI 1997/2043 Amends the entries for methionine and paracetamol so that those two substances combined are not on the general sale list, amends the entry for camphor and includes liquid preparations of paracetamol, with different provisions for maximum strength and dosage for adults and children aged under 12. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1998, SI 1998/2170 The GSL Order (1984) is amended by adding entries for bugleweed, potassium chloride, benzocaine and lauromacrogols, amending the entry for lignocaine and phenolphthalein deleted. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 1999, SI 1999/852 Amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 which specifies the medicinal products which can be sold or supplied without the supervision of a pharmacist by deleting an entry for Methionine, and inserting an entry for Nicotine chewing gum. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 2000, SI 2000/1092 Amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 by adding an entry for Mepyramine Maleate for products of maximum strength 2.0 per cent for use of symptomatic relief of insect stings and bites and nettle stings in adults and children aged 2 and over. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 2001, SI 2001/2068 The GSL Order (1984) is amended by adding definitions and amending the table of substances to allow for prolonged-release products, adding an entry for gum ammoniacum and amending entries for cetylpyridonium chloride, nicotine and clotrimazole. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 2002, SI 2002/933 Amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 to include medicinal products which have been granted a marketing authorisation if they have been classed as being available for on general sale and medicinal products which have not been granted a marketing authorisation or a product licence of right will continue to be classified as general sale if they contain substances listed in Schedule 1 or 2 of the Order. Read More… (opens in a new window)
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Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984, SI 1984/769 Amends the Medicines (General Sale List) order 1980 so that it no longer includes veterinary drugs, medicinal products are specified by composition only rather than by name and product licence number and the automatic machines section of the Order is extended to include all general sale list medicines. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 3) Order 2004, SI 2004/2693 This order adds additional medicines to the list of injectable medicines which can be administered by anyone for the purpose of saving life in an emergency; allows members of the armed forces to administer smallpox vaccine in the event of a confirmed or suspected case of smallpox; also allows nurse prescribers to administer certain medicines in palliative care and adds Amiodarone to be administered by paramedics for immediate, necessary treatment of sick or injured persons. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 1997, SI 1997/2044 Amends the entry for carbenoxolone sodium, the entry for all products containing terfenadine so that they are prescription only medicines, and includes products which contain aspirin or paracetamol with provisions to exempt certain products from being prescription only medicines. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 1998, SI 1998/108 Ends the exemption for insulin for injection and amends the conditions for other products under which they could be sold or supplied otherwise than as a prescription only medicine. Adds new substances which can be prescribed by appropriate nurse practitioners and provides a list of substances which may supplied or administered by appropriately qualified chiropodists. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 1999, SI 1999/1044 Updates the conditions for sale and supply of aspirin 75mg without a prescription, adds new substances to the list of prescription only medicines, inserts conditions for the supply of hydrocortisone in combination with nystatin and amends the entry for beclomethasone dipropionate. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 2000, SI 2000/1917 Amends the Prescription Only Medicines (Human Use) Order 1997 to provide exemptions from restrictions in the Medicines Act for the supply of Prescription Only Medicines in the NHS or in a pharmacy in certain circumstances, amends the specified substances which if included in medicinal products mean they have to be classified as Prescription Only Medicines, and provides various exemptions for other substances. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 2001, SI 2001/2777 Amends the Prescription Only Medicines (Human Use) Order 1997 by changing the conditions under which certain medicinal products may be sold or supplied other than as Prescription Only Medicine, and adds certain substances. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 2002, SI 2002/549 Allows nurse prescribers to prescribe certain products and makes provision for the regulation of certain health professions. Medicinal products which have been granted a marketing authorisation will be prescription only medicines if so classified in their marketing authorisation or, where no authorisation has been granted, will continue to be classified as prescription only if they contain a substance listed in the Schedule. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 2003, SI 2003/696 Allows nurses and pharmacists to prescribe prescription only medicines in accordance with clinical management plans relating to individual patients as supplementary prescribers, sets out the requirements for a valid clinical management plan and extends the use of patient group directions to certain non-NHS healthcare providers. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 2004, SI 2004/2 Extends the circumstances in which medicines can be sold or supplied in accordance with the directions of an appropriate practitioner without the usual prescription requirements. It amends the list of medicines which can be prescribed by extended formulary nurse prescribers and allows registered midwives to administer injectable diamorphine and morphine. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment Order 2008, SI 2008/464 Removes a restriction on the prescribing of controlled drugs by Nurse Independent Prescribers, introduces the prescribing of controlled drugs by Pharmacist Independent Prescribers and makes the sale and supply to a person at any one time of products containing more than a certain amount of pseudoephedrine salts or ephedrine base or salts subject to prescription. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 2) Order 1998, SI 1998/1178 Amends the Prescription Only Medicines (Human Use) Order 1997 which (subject to exemptions) specifies what medicines are only available on prescription and who may prescribe them by making changes to the status of various substances. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 2) Order 1999, SI 1999/3463 Amends the Prescription Only Medicines (Human Use) Order 1997 which (subject to exemptions) specifies what medicines are only available on prescription and who may prescribe them by changing the status of various substances, making several Prescription Only. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 2) Order 2000, SI 2000/2899 Amends the conditions under which certain medicinal products can be sold or supplied without a prescription, adding several new substances to the list classed as prescription only and further extends the range of medicines which registered paramedics can administer on their own initiative. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 2) Order 2001, SI 2001/3942 Amends the Prescription Only Medicines (Human Use) Order 1997 which (subject to exemptions) specifies what medicines are only available on prescription and who may prescribe them by making changes to the status of various substances. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 2) Order 2003, SI 2003/2915 Amends the Prescription Only Medicines (Human Use) Order 1997 which (subject to exemptions) specifies what medicines are only available on prescription and who may prescribe them amending the definition of “Patient Group Direction” and the list of substances that can be prescribed by certain nurses is expanded. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 2) Order 2004, SI 2004/1189 Changes the permitted use or route of administration for certain substances when prescribed or administered by an extended formulary nurse prescriber, extends the range of medicines which can be administered by paramedics and adds certain health care professionals to the group who can administer prescription only medicines under a Patient Group Direction. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 3) Order 1998, SI 1998/2081 Amends the Prescription Only Medicines (Human Use) Order 1997 which (subject to exemptions) specifies what medicines are only available on prescription and who may prescribe them amending the restrictions on and categories of substances and medicines that are prescription only. Read More… (opens in a new window)
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Prescription Only Medicines (Human Use) Amendment (No 3) Order 2000, SI 2000/3231 Allows Levonorgestrel to be sold or supplied without a prescription in certain circumstances. Read More… (opens in a new window)
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Medicines (Pharmacy and General Sale) (Appointed Day) Order 1977, SI 1977/2126 This Order sets that after 1st February 1978 only medicinal products specified on the general sale list may be sold or supplied anywhere so long as certain conditions are met, only certain specified medicinal products can be sold by an automatic machine, and medicinal products not on the general sale list may only be sold or supplied on premises which are a registered pharmacy and by or under the supervision of a pharmacist Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1997, SI 1997/1831 Makes changes to the record keeping for medicines either being sold or supplied by allowing written or computerised record keeping. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2003, SI 2003/698 A retail pharmacy must record the sale and supply of medicines prescribed on a private basis by supplementary prescribers, district nurse/health visitor prescribers and extended formulary nurse prescribers. Persons who may be supplied with prescription medicine on a wholesale basis are also added. Read More… (opens in a new window)
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Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010, SI 2010/1882 Implements certain enforcement obligations laid down in the European Regulation on advanced therapy medicinal products ATMPs (EC No 1394/2007) and introduces specific requirements for ATMPs without changing the definition of a medicinal product. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2006, SI 2006/914 Imposes restrictions on sale or supply of medicinal products for human use, indicating who is qualified to act as a prescriber on the nurse’s register, imposes requirements on the packaging of certain medicinal products in the Child Safety regulations and reflects changes in the Nurse’s Register in the Traditional Herbal Medicinal products regulations Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2008, SI 2008/1162 Sets out that retail pharmacies must record the sale and supply of a prescription medicine except in response to a health prescription, including a prescription issued by an optometrist. The packaging requirements of the Child Safety Regulations do not apply to the sale or supply by a pharmacy of a prescription medicine requested by an optometrist. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2005, SI 2005/764 Impacts upon medicines consolidation policy by adding chiropodists, podiatrists, physiotherapists and diagnostic or therapeutic radiographers to the list of supplementary prescribers, changing the wholesale sale and supply of prescribed medicines to an ophthalmic optician and changing the maximum number of tablets which may be contained in a pack of Bisacodyl. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2007, SI 2007/2179 Impacts on fees for blood safety and quality services by increasing the fees for blood establishments and hospital blood banks by approximately 1% for authorisation, operation, and haemovigilance services and introducing a fee for written representations to, or appearing before, a person appointed by the Secretary of State. Read More… (opens in a new window)
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Medicines (Chloroform Prohibition) Amendment Order 1980, SI 1980/263 Allows for the wholesale dealing of tooth pastes which contain not more than four per cent of chloroform for implementing Council Directive 79/661 relating to Cosmetic products. Read More… (opens in a new window)
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The Medicines Act 1968 (Hearings by Persons Appointed)(Scotland)Rules 1986 SI 1986/1700 Sets out the procedure to be followed in connection with hearings by persons appointed under the Medicines Act 1968 or by associated regulations. These hearings form part of the procedures for licensing medicinal products and registering pharmacies. Read More… (opens in a new window)
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Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986, SI 1986/1761 Prescribes the procedure to be followed in connection with hearings by persons appointed under the Medicines Act 1968 or under regulations made under section 60 of that Act. These hearings form part of the licensing procedures for medicines and the procedure for registration of premises as registered pharmacies. Read More… (opens in a new window)
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Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2009, SI 2009/2820 Amends current legislation to make clear that the MHRA can reject a UK Marketing Authorisation without consulting the CHM if an applicant fails to respond to a request for further information. Read More… (opens in a new window)
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Medicines (Advisory Board on the Registration of Homeopathic Products) Amendment Order 2006, SI 2006/2386 Extends the functions of the Advisory Board on the Registration of Homoeopathic Products to include providing advice on the safety, quality and efficacy of homeopathic medicinal products. Read More… (opens in a new window)
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Medicines (Advisory Bodies) (No 2) Regulations 2005, SI 2005/2754 Makes changes to the structure of the advisory bodies which provide advice on medicines by abolishing the Medicines Commission and creating the Commission on Human Medicines (CHM) and the Herbal Medicines Advisory Committee. Read More… (opens in a new window)
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Medicines (Advisory Bodies) (Terms of Office of Members) Regulations 2005, SI 2005/2788 Sets out the maximum term of office for chairmen and members of the Commission on Human Medicines and related committees and Expert Advisory Groups, and how cessation of membership of particular committees affects membership of other committees. Read More… (opens in a new window)
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Medicines (Advisory Bodies) Regulations 2005, SI 2005/1094 Abolishes the Medicines Commission and the Committee on Safety of Medicines and establishes the Commission on Human Medicines. Read More… (opens in a new window)
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Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995, SI 1995/309 The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1994 is revoked and a new Advisory Board on the Registration of Homoeopathic Products is established. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, SI 1971/1450 Exempts from the restrictions imposed by the Medicines Act 1968 as to the manufacture of medicinal products except in accordance with a licence under that Act and certain medicinal products manufactured in particular circumstances, provided specified conditions are satisfied. Read More… (opens in a new window)
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Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 SI 1974/832 Amends the provisions for renewal applications for product licences, clinical trial certificates, manufacturer’s licences and wholesale dealer’s licences and renewal applications for licences or certificates for veterinary drugs by setting out the way in which the application should be made, the information that should be provided, when the application should be made and setting a transitional provision for renewing product licences which are licences of right. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Food and Cosmetics) Amendment Order 1973, SI 1973/2079 Adds to the cases to which the exemptions from licensing do not apply, the cases where the medicinal product is being advertised in a certain way to practitioners; and cases where the medicinal product being a cosmetic within the meaning of the Order of 1971, contains hexachlorophane. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Special and Transitional Cases) (Amendment) Order 1989, SI 1989/2323 Amends the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 and the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 by extending the definition of “medicinal product” to include “intermediate feed”. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Special and Transitional Cases) Amendment Order 1989, SI 1989/1184 Extends the product licence exemption to the holder of a manufacturer’s licence, relating only to the assembly of special manufactured products and allowing manufacturers in certain circumstances to hold a manufacturer’s licence. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment (No 3) Regulations 1977, SI 1977/1053 These provide for further standard provisions to be included into manufacturer’s and wholesale dealer’s licences and, where proprietary medicinal products are included, obligations under directives 65/65 and 75/319 must apply. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1972, SI 1972/1226 Amends underlying regulations to add requirements for clinical trial and animal test certificates, manufacturer’s licences and wholesale dealer’s licences. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1977, SI 1977/675 Amends underlying regulations by adding two new schedules relating to manufacturer’s licences for vaccines and to product licences for substances whose quality and potency cannot be tested by chemical means. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992, SI 1992/2846 Implements the principles of good manufacturing practice to be carried out by manufacturers, wholesale dealers and importers of medicinal products for human use within the European Community and also states additional requirements for product and manufacturing licences for certain immunological products, radiopharmaceuticals and products derived from human blood or human plasma. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1993, SI 1993/833 Implements part of the European Directive on wholesale dealing relating to emergency planning for recalls, record keeping and responsible persons. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994, SI 1994/103 Widens the scope for the requirements laid by law, regulation or administration action relating to medicinal products and wholesale dealers and their licences, including additional requirements for the manufacturer of homeopathic medicinal products. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999, SI 1999/4 Introduces new requirements for holders of wholesale dealer licences who import medicinal products for the purpose of sale and supply where a marketing authorisation licence is not required including notifying the licensing authority of importation, record keeping and setting maximum quantities for import. Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 2004, SI 2004/1678 Implements Article 46 of European Directive 2001/83/EC relating to Good Manufacturing Practice (GMP). Read More… (opens in a new window)
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Medicines (Termination of Transitional Exemptions) (No 1) Order 1972, SI 1972/1198 Appoints the 1st December 1972 as the date upon which the transitional exemptions relating to clinical trials and medicinal tests on animals shall cease to have effect. Read More… (opens in a new window)
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Medicines (Termination of Transitional Exemptions) (No 2) Order 1974, SI 1974/1149 Appoints 1st September 1972 as the day upon which the transitional exemptions from the licensing requirements of the Medicines Act 1968 stop being effective, except in relation to ingredients that are medicinal products and wholesale dealing in certain human medicinal products and the day for the ending of the transitional exemptions in relation to such ingredients. Read More… (opens in a new window)
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Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992, SI 1992/605 Apply to radiopharmaceutical kits, generators and precursors and implement part of Council Directive 89/34 which relate to radiopharmaceuticals and also provides transitional protection until December 31, 1992 for products on the UK market before 3rd April 1992 (Regulation 3). Read More… (opens in a new window)
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Medicines (Control of Substances for Manufacture) (Appointed Day) Order 1985, SI 1985/1539 Appoints 15th October 1985 as the day from which licensing restrictions shall be applied to gentamicin, neomycin and nystatin where they are used as ingredients in the manufacture of medicinal products. Read More… (opens in a new window)
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Medicines (Exemption from Licences) (Ingredients) Order 1974, SI 1974/1150 Allows exemptions from the restrictions imposed in the Medicines Act 1968 relating to dealings in and manufacture of medicinal products, applying if certain conditions as to notification or making an appropriate licence application are complied with unless the activity in question takes place during the period specified before 1st January 1975. Read More… (opens in a new window)
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Medicines (Medicines Act 1968 Amendment) Regulations 1977, SI 1977/1050 The Medicines Act of 1968 is amended to enable implementation of the European medicines directives in respect to licences required for selling and distributing products imported from outside the EEC; treatment of product licence dossiers received by regulatory agencies; refusal, suspension and revocation of licences; and the duration of licences which do not comply with the European directives. Read More… (opens in a new window)
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Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2000, SI 2000/292 Not complying with the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products” is introduced as an offence and amends the special warnings that must be included on the packaging of medicinal products containing paracetamol on the general sale list. Read More… (opens in a new window)
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Medicines (Medicines Act 1968 Amendment) Regulations 1983, SI 1983/1724 Adds the requirement of a person responsible for placing on the market in the United Kingdom veterinary drugs which are proprietary medicinal products or ready-made veterinary drugs to hold licences and also to require distributors of such drugs imported from outside the European Communities to hold licences. Read More… (opens in a new window)
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Medicines Act 1968 (Amendment) Regulations 1992, SI 1992/604 Amends the Medicines Act 1968 to cover products for human use which had previously not been within the scope of the regulations including; immunological products, medicinal products based on human blood or blood constituents, and medicinal products based on radioactive isotopes (other than isotopes which are sealed sources). Read More… (opens in a new window)
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Medicines (Control of Substances for Manufacture and Exportation of Specified Products for Human Use) Amendment Order 1994, SI 1994/787 Relates to substances for veterinary use by allowing the exportation of the medicinal products with the exceptions of (antigens, antitoxins, Sera, antisera, toxins and vaccines) however, to export to a member state of the European Community, a wholesale dealer’s licence will be required. Read More… (opens in a new window)
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Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005, SI 2005/1710 Introduces new criminal offences of providing false or misleading information in support of an application for the grant, renewal, or variation of a marketing authorisation for a medicinal product. Read More… (opens in a new window)
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Medicines (Control of Substances for Manufacture) (Revocation) Order 1997, SI 1997/1728 Revokes the Medicines (Control of Substances for Manufacture) Order 1982 as part of the implementation by the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997 of Council Directive 96/22/EEC concerning the prohibition on the use in livestock farming of certain substances that have a hormonal or thyrostatic action and of beta-agonists. Read More… (opens in a new window)
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Medicines (Control of Substances for Manufacture) Order 1971, SI 1971/1200 Extends certain provisions of the Medicines Act 1968 so that they will also relate to the substances described in Schedule 1 to this order. Read More… (opens in a new window)
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Medicines (Control of Substances for Manufacture) Order 1985, SI 1985/1403 These regulations, which are part of the the medicines consolidation, cover manufacturing authorisations, wholesale dealer’s licensing, packaging and labelling (and offences related to these areas) for medicines whose ingredients include gentamicin, neomycin and nystatin covering all means of administration for these medicines including parenteral injection. Read More… (opens in a new window)
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Medicines (Cyanogenetic Substances) Order 1984, SI 1984/187 Amends the requirements in the Medicines Act 1968 for preparations which are not medicinal products but are either presented for sale or supply as (or as containing) amygdalin, laetrile or vitamin B17 or contain the cyanide-producing substances relating to the administration and dealings with these products, the packaging and promotion of products and criminal offences created to enforce those requirements. Read More… (opens in a new window)
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Medicines (Committee on Dental and Surgical Materials) (Revocation) Order 1994, SI 1994/3120 Abolishes the Committee on Dental and Surgical Materials following the implementation of Council Directive 93/42/EEC concerning medical devices. Read More… (opens in a new window)
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Medicines (Committee on Radiation from Radioactive Medicinal Products) (Revocation) Order 1984, SI 1984/1261 Abolishes the Committee on Radiation from Radioactive Medicinal Products. Read More… (opens in a new window)
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Medicines (Committee on the Review of Medicines) (Revocation) Order 1992, SI 1992/606 Revokes the Medicines (Committee on the Review of Medicines) Order 1975 as the review of medicines is complete and the committee abolished. Read More… (opens in a new window)
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Medicines (Contact Lens Fluids and Other Substances) (Appointed Day) Order 1979, SI 1979/1539 Specifies that from 1st January 1980, licensing restrictions will apply to the marketing, manufacture, wholesale dealing and clinical trials concerning substances and fluids used with contact lenses Read More… (opens in a new window)
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Medicines (Exemptions from Licences) (Revocation) Order 1996, SI 1996/2195 Revokes the Medicines (Exemptions from Licences and Animal Test Certificates) Order 1986 and the Medicines (Exemptions from Licences and Animal Test Certificates) (Amendment) Order 1991 Read More… (opens in a new window)
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Medicines (First Appointed Day) Order 1971, SI 1971/1153 The 1st September 1971 is appointed as the day from which various provisions in the Medicines Act 1968 take effect. Read More… (opens in a new window)
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Medicines (Monitoring of Advertising) Amendment Regulations 1999, SI 1999/784 Specifies the maximum statutory conviction for an offence committed under the Medicines (Monitoring of Advertising) Regulations 1994 Read More… (opens in a new window)
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Medicines (Monitoring of Advertising) Regulations 1994, SI 1994/1933 Implements Article 12 of Council Directive 92/28/EEC concerning the advertising of medicinal products for human use by specifying procedures whereby persons or organisations may bring an advertisement which is inconsistent with the requirements of the Directive before an administrative authority competent either to decide on complaints or to institute civil proceedings in the High Court. Read More… (opens in a new window)
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Medicines (Advertising Amendments) Regulations 2005, SI 2005/2787 Amends advertising of medicinal products for human use. Contain measures relating to: removing prohibitions, changing wording on hospitality at promotional events, application of rules to traditional herbal medicinal products and certain homeopathic products. Read More… (opens in a new window)
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Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999, SI 1999/267 These regulations impact upon medicines regulation consolidation and the advertising of medicines by adding definitions for specific groups such as “the Health Ministers”, specifying the general principles for the advertising of medicines and responsibilities of marketing authorisation holders, amending the definitions of offences and introduces a new notices procedure for the scrutiny of print advertisments Read More… (opens in a new window)
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Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1974, SI 1974/1523 Provides guidance for manufacturing authorisation holders concerning the contents, terms, form, and distribution of advertisements relating to medicines Read More… (opens in a new window)
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Medicines Act 1968 (Amendment) Regulations 1995, SI 1995/2321 Relates to the Medicines Act by excluding relevant medicinal product from the Medicines Act requirements for advertising. Read More… (opens in a new window)
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Medicines (Advertising) Amendment Regulations 1996, SI 1996/1552 Allows medicines for the treatment of sprains, rheumatic or non-serious arthritic conditions to be advertised and stating that medicines for the treatment of joint, rheumatic and collagen diseases may not be advertised Read More… (opens in a new window)
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Medicines (Advertising) Amendment Regulations 2004, SI 2004/1480 Removes the prohibition on advertising to the public medicines for the treatment, prevention or diagnosis of a number of disorders including cardiovascular and genetic disorders, and confirming that it is not allowed to advertise medicines for disorders such as diabetes or sexually transmitted diseases Read More… (opens in a new window)
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Medicines (Advertising) Regulations 1994, SI 1994/1932 Relates to the advertising of medicinal products for human use, and include homeopathic products. Set out offences in relation to advertising without a product licence, and deal with requirements for advertising of products to the public and health professionals. Read More… (opens in a new window)
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Medicines (Advertising of Medicinal Products) (No 2) Regulations 1975, SI 1975/1326 Provides that particulars relating to medicines for human use in certain advertisements issued in professional publications are to be consistent with the relevant data sheet and that such advertisements must contain a notice that a data sheet relating to the product advertised will be sent on request to any doctor or dentist. Read More… (opens in a new window)
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Medicines (Advertising of Medicinal Products) Regulations 1975, SI 1975/298 Apply only to those medicines which have a product licence of right prohibiting the issue of advertisements unless the relevant product licence includes certain provisions relating to advertisements, the licensing authority have given their consent or they have not specified, within a limited time, that a particular advertisement should not be issued. Read More… (opens in a new window)
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Medicines (Labelling and Advertising to the Public) Regulations 1978, SI 1978/41 Made under the Medicines Act 1968 and impose requirements and restrictions for advertisements directed to the public relating to medicine products and other substances and articles for human use. Also prohibit advertisement of certain medicinal products. Read More… (opens in a new window)
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Medicines (Child Safety) Regulations 2003, SI 2003/2317 Relates to the packaging of medicines consisting of aspirin, paracetamol or more than 24 mg of elemental iron in child resistant containers and the colouring of solid dosage forms of aspirin and paracetamol and includes the exemptions for doctors dentists and pharmacists. Read More… (opens in a new window)
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Medicines (Labelling) Amendment Regulations 1985, SI 1985/1558 These Regulations amend the Medicines (Labelling ) Regulations 1976 to ensure that medicines packaging and containers are clearly labelled with an expiry date. Read More… (opens in a new window)
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Medicines (Labelling) Amendment Regulations 1992, SI 1992/3273 Amends the Medicines (Labelling) Regulations 1976 relating to requirements for the labelling of packaging and containers for medicines which have been licensed on or after January 1st 1994. Read More… (opens in a new window)
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Medicines (Leaflets) Amendment Regulations 1992, SI 1992/3274 Lays down the requirements for the form and content of leaflets supplied with certain medicinal products so that the contents are according to the summary of product characteristics and are printed in English and other languages, and imposes the procedure for notifying the licensing authority of alterations to leaflets. Read More… (opens in a new window)
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Medicines (Leaflets) Regulations 1977, SI 1977/1055 These Regulations made under the Medicines Act 1968 implement certain EU obligations under Council Directive 75/319/EEC which relates to ready-prepared medicines, describing what should be contained in the leaflets supplied with such products. Read More… (opens in a new window)
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Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004, SI 2004/3224 Implements certain provisions of Directive 2004/27/EC which relate to the provision of information by marketing authorisation holders for medicines, the accompanying package leaflets and decisions by the MHRA concerning their classification and consequential amendments are also made due to the establishment of the European Medicines Agency. Read More… (opens in a new window)
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Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 1998, SI 1998/3105 Makes changes to the Medicines for Human use Medicines for Human use(Marketing Authorisations Etc.) Regulations 1994by requiring necessary special warnings be included on the packaging and package leaflets of relevant products containing paracetamol for both adult and paediatric use, that they must be prominent and in a rectangle and that breach of these requirements is a criminal offence. Read More… (opens in a new window)
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Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2003, SI 2003/1618 Amends the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, by requiring products containing aspirin or aloxiprin to have warnings included on their packages and leaflets. Read More… (opens in a new window)
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Medicines (Labelling) Regulations 1976 SI 1976/1726 Sets out standard labelling requirements for containers and packages of medicinal products and also sets out special labelling requirements for products, such as those used in trials or tests, or in animal feeding stuffs, including various exemptions. Read More… (opens in a new window)
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Medicines (Fluted Bottles) Regulations 1978, SI 1978/40 Prohibits the sale or supply of certain medicinal products for external use, unless they are in bottles which are recognisable by touch for identification of the product in promoting safety where breach of these regulations would be a criminal offence. Read More… (opens in a new window)
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Medicines (Data Sheet) Regulations 1972 SI 1972/2076 Replaces the Medicines (Data Sheet) (Transitional) Regulations 1971 by setting out the requirements for data sheets which (under the Medicines Act 1968) manufacturers are required to send to healthcare practitioners in connection with any advertisement or representation of a medicinal product, under the Medicines Act 1968. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No 3) Regulations 2000, SI 2000/2494 Further amends the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 by making changes to the pack sizes of medicinal products containing bisacodyl, famotidine or heparinoid that are on a general sale list. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1982, SI 1982/28 Changes the sale or supply of medicinal capsules that are on the General Sales List and contain aloxiprin, aspirin, paracetamol or salicylamide by allowing these capsules to be sold and supplied by retail elsewhere other than a registered pharmacy but only in packs of 25 or less. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1990, SI 1990/1124 Amends the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 limiting the size of Bisacodyl packs on the general sale list to 10 tablets. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1994, SI 1994/2411 Amends the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980, limiting the pack size of effervescent tablets containing between 325 and 500 milligrams of aspirin on the general sale list to 20 tablets. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1995, SI 1995/3215 These regulations make changes to the sale and supply of medicinal products Ibuprofen and Clotrimazole by changing the limits on pack sizes and allowing certain pack sizes which are on the General Sales List, to be sold at retail elsewhere other than pharmacy, but only in separate or individual containers or packages. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1999, SI 1999/644 These regulations impact upon medicines consolidation and patient information specifying that the maximum pack size of non-effervescent medicines containing aloxiprin, sold or supplied through outlets other than pharmacies, are reduced from 25 tablets or capsules to 16 and that medicines containing ibuprofen, sold or supplied through outlets other than pharmacies, may not contain more than 16 capsules or tablets Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2000, SI 2000/1070 Provides that medicinal products containing mepyramine maleate and which are on the general sale list may be sold or supplied from outlets other than registered pharmacies only in separate and individual containers or packages containing not more than 20 grams of the product. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2001, SI 2001/3849 Amends the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1990 relating to the pack size for the sale or supply of certain medicines on the general sales list (medicines that can be sold from outlets other than registered pharmacies). Read More… (opens in a new window)
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Medicines (Data Sheet and Labelling) Amendment Regulations 1989, SI 1989/1183 Impacts upon medicines consolidation and patient information amending a number of regulations coming into force on 31 July 1989, 1 August 1989 and 1 February 1990. Read More… (opens in a new window)
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Medicines (Data Sheet) Amendment Regulations 1981, SI 1981/1633 Impacts upon medicines consolidation and patient informationso that there is no requirement to provide the dimensions of a data sheet for inclusion in a data sheet compendium Read More… (opens in a new window)
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Medicines (Data Sheet) Amendment Regulations 1996, SI 1996/2420 Amends the Medicines (Data Sheet) Regulations 1972 removing certain requirements relating to the compilation of data sheets for medicines for human use. Read More… (opens in a new window)
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Medicines (Labelling) Amendment Regulations 1981, SI 1981/1791 These regulations impact upon medicines consolidation and patient information in that where the status of a medicine is changed, the medicine may continue with its previous labelling for up to six months and larger packs of certain medicines may be sold only at a pharmacy. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 1997, SI 1997/2045 Amends the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1990. Measures include removal of provisions relating to pack sizes for salicylamid; and reducing maximum pack size of non-effervescent tablets and capsules containing aspiring or paracetamol. Read More… (opens in a new window)
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Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 1999, SI 1999/2510 Impacts upon medicines consolidation and patient information stating medicines containing ranitidine hydrochloride may not contain more than 12 tablets in a container unless sold or supplied through a pharmacy |
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Medicines (Renewal Applications for Licences and Certificates) (Amendment) Regulations 1977, SI 1977/180 Amends the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 in respect of applications for the first renewal of product licences of right made between 1st March and 30th June 1977 or a later date as allowed by the licensing authority. Read More… (opens in a new window)
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Medicines (Renewal Applications for Licences and Certificates) Amendment Regulations 1982, SI 1982/1789 Amends the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 which makes provision for what items need to be included in, or accompany, an application for the renewal of a medicines licence under section 24 of the Medicines Act 1968 or of a certificate under section 38 of that Act. Read More… (opens in a new window)
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Medicines Act 1968 (Amendment No 2) Regulations 1992, SI 1992/3271 Amends the Medicines Act 1968 to implement Council Directive 92/26/EEC (Classification of Human Medicines Directive) and 90/676/EEC (Veterinary Medicines Directive). Sets down criteria to be applied in specifying which medicines for human use, and veterinary medicinal products, are to be supplied only on presecription. Read More… (opens in a new window)
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Medicines for Human Use (Marketing Authorisations Etc) Amendment Regulations 2008, SI 2008/3097 Amends the Medicines for Human Use (Marketing Authorisation Etc.) regulations (“the 1994 Regulations”) to introduce additional criminal offences for breaches to the European Paediatric Regulation (EC) No 1901/2006, as required by that Regulation. Read More… (opens in a new window)
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Medicines for Human Use (Miscellaneous Amendments) Regulations 2009, SI 2009/1164 Sets out the requirements for applications to the licensing authority to renew licences that have been granted concerning medicinal products including product licences, manufacturer’s licences, and wholesale dealer’s licences. Read More… (opens in a new window)
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Medicines (Contact Lens Fluids and Other Substances) (Advertising and Miscellaneous Amendments) Regulations 1979, SI 1979/1760 Amends the Medicines (Data Sheet) Regulations 1972, relating to substances and fluids used with contact lenses and the data sheets used to advertise such products to healthcare professionals. Read More… (opens in a new window)
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Tell us what you think should happen to these regulations and why, being specific where possible:
- Should we scrap them altogether?
- Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
- Could they be reformed, simplified or merged? How?
- Can we reduce their bureaucracy through better implementation? How?
- Can we make their enforcement less burdensome? How?
- Should they be left as they are?
most medicine legislation ,whether EU or Uk makes sense ,in particular the safety aspect of it,but what makes no sense at all and costs the Pharma companies large amounts of money (and yes ,profits ) is the way most of the regulation is handled by the MHRA
For example where a CTD which has been approved in another member state is submitted it should be possible to issue a MA within 30 days but it can take up to 2 years, why, we are all supposed to be using the same rules ?
similarily with small variations why do they take so long things like name changes should only take a few days and each day the query stays at the MHRA the more money the industry loses
There is not much wrong with the regulation just the way it is managedComment Tags: MA, MHRA delays, variations