Medicinal Act

It is one of the peculiarities of herbal drugs that their indications have for the most part been determijied empirically. The reason is easily understood most herbal drugs have been used for a very long time to alleviate or cure illnesses and more especially disorders. Their introduction in therapeutics happened at a time when pharmacodynamics and pharmacokinetics were unknown concepts, when there was no Medicines Act to require proof of the quality, efficacy, and innocuity of herbal medicines. Today, when introducing a new medicine, extensive investigations are required in the interest of safety. To many the requirement of the proof of activity of such a drug as chamomile appears to be superfluous, but nevertheless, as a representative of a scientifically oriented pharma-... 

Compliance with the principles of GMP is one of the major factors considered by the Licensing Authority when examining an applicahon for a licence to manufacture under the Medicines Act (1968). Similar codes exist in the USA and other countries. 

All amphetamines are prescription only drugs under the Medicines Act. Most are also controlled under the Misuse of Drugs Act. Doctors can prescribe them for patients but it is an offence to be in possession of amphetamines without a prescription. Most amphetamines are controlled as class B drugs under the Misuse of Drugs Act. Maximum penalties for possession are 5 years imprisonment plus a fine and for supply are 14 years imprisonment and a fine. If amphetamines are prepared for injection they become class A drugs and increased penalties apply. 

In the United Kingdom, the Committee on Safety of Medicines (reporting to the Minister of Health) regulates drug safety and development under the Medicines Act... 

Nitric oxide, NO, plays a number of roles in human physiology, including acting as a smooth muscle relaxant. Several drugs employed in clinical medicine act by supplying or increasing the levels of NO. 

Many substances can affect metabolic processes by influencing the activity of enzymes. Enzyme inhibitors are particularly important here. A large proportion of medicines act as enzyme inhibitors. Enzyme-kinetic experiments are therefore an important aspect of drug development and testing procedures. Natural metabolites are also involved in regulatory processes as inhibitors (see p.ll4). 

The United Kingdom Medicines Act 1968 regulations require that all medicinal products are properly labelled to certain minimum standards, but requirements vary from country to country. Clinical trial materials, however, cannot be labelled normally because if the trial is blind, nothing should reveal to the patient or physician the nature of the contents. The basic information on the label should provide the patient s name, study phase, study number, directions for use, any special warning or storage requirements, expiry date and the investigator s name and address, along with an indication that the... 

Medicines Control Agency. Medicines Act 1968. Guidance Notes on Applications for Clinical Trial Exemptions Clinical Trial Certificates. Revised December 1995. London HMSO, 1995. 

The issue of any promotional material that is not in accord with the MA, is inconsistent with labelling approved by the regulatory authority and is misleading is a criminal offence imder the Medicines Act (1968) and carries financial penalties and potential for a custodial sentence. Conviction of such an offence usually leads to erasure from the Medical Register by the General Medical Council (GMC). 

The EU has approved Council Directive No. 92/28/EEClO (of 31 March 1992, now consolidated as Articles 86 to 100 of Directive 2001/83/EC) on the advertising of medicinal products for human use, thus bringing Member States into line with common requirements and standards. The UK regulations have been amended to comply with the Directive. The Directive, Part IV of the UK Medicines Act 1968 as amended by the Advertising Regulations, and the ABPl Code of Practice for the Pharmaceutical Industry are broadly in line with one another. The commentary below on promotion relates primarily to the United Kingdom. While there have been some moves towards the international harmonisation of controls on promotion, these have had only a limited effect, despite the fact that in Europe, Member States all comply with Directive 92/28. 

Finally, the representative must learn the details of the product licence and thus know how, when promoting the product, to avoid being in breach of either the Medicines Act or the ABPI Code of Practice, which is written specifically to assist company personnel in promoting products to prescribers in an appropriate manner. 

The original provisions date back to the early 1970s. Under section 7(2) of the Medicines Act 1968, it was necessary to hold a product licence in order to sell, supply, export or import a medicinal product to procure those activities or for the manufacture or assembly of the product. However, various exemptions from the licensing requirements, including those relating to particular patient supply, were provided for in the act and in related statutory instruments. The most important exemptions were contained in sections 9 and 13 of the act, the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and the Medicines (Exemptions from Licences) (Importation) Order 1984. ... 

Medicines Act for relevant medicinal products, including section 7 (and consequently all exemptions relating to section 7). Relevant medicinal products are defined in the 1994 Regulations as those medicinal products for human use to the provisions of Directive 2001/83/EC apply. This broad definition includes most medicinal products. The exceptions are medicinal products for clinical trial use, products prepared in a pharmacy in accordance with a pharmacopoeial formula for direct supply to a patient, intermediate products, registered homoeopathic products, non-industrially produced herbal remedies and some products which are not medicinal products within the meaning of the Directive, but which by order have been made subject to control under the Medicines Act 1968. For products designated under such an order, the old provisions on particular patient supply are still applicable. In practice, there are very few such products. 

Section 8(2) of the Medicines Act 1968 requires those involved in the manufacture or assembly of a medicinal product to hold a manufacturer s licence. In fact. Schedule 1 to 1994 Regulations requires the manufacturer/assembler in the United Kingdom of an unlicensed product for particular patient supply to hold a particular type of manufacturer s licence (a manufacturer s special licence). It should also be noted that Section 23 of the act prohibits the manufacture of a medicinal product unless that product has a marketing authorisation, or is exempt from the marketing authorisation requirement. 

The CSD was serviced by a professional secretariat of pharmacists and medical officers who undertook the assessment of the submissions and presented these to the Committee and its various subcommittees. The secretariat initially included three doctors and two pharmacists. In 1965, the number of professional staff had been increased to six doctors and three pharmacists. Among the six doctors was Dr Denis Cahal, who headed the secretariat. Others were Drs J Broadbent, M Hollyhock, WH Inman, D Mansel-Jones and C Ruttle. The secretriat, known as the Medicines Division, was created as a branch of the Department of Health. The close collaboration between Dr Cahal and Sir Derrick Dunlop was pivotal in guiding the Medicines Act through Parliament in 1968 and setting the foundation of a system that became a model to the rest of the world for fairness and efficiency. 

The membership of the Committee on Safety of Drugs and its subcommittees changed further following the resignation of Sir Derrick Dunlop in May 1969, as a result of his appointment as the first Chairman of the Medicines Commission (MC), estabhshed under the Medicines Act 1968. 

Professor AC Frazer was appointed to succeed Sir Derrick but imfortimately he died shortly thereafter. During 1969, therefore. Professor EF Scowen succeeded Professor Frazer as the Chairman of the Committee. In June 1970, the membership of the Committee was revised to correspond with that of the then newly established (under section 4 of the Medicines Act 1968) Committee on Safety of Medicines (CSM). The full... 

Full voluntary cooperation was clearly not as assured as might have been anticipated. During 1965, the CSD itself seemed to articulate in its Annual Report a carefully concealed aspiration for the introduction of statutory controls on drug regulation. After a period of review and consultation, a White Paper Forthcoming Legislation on the Safety, Quality and Description of Drugs and Medicines was published in September 1967 and the Medicines Act based on these proposals... 

The Act has been frequently amended as appropriate to ensure that it is in line with the European community legislation. Given the remarkable degree of similarity between the requirements under the Medicines Act 1968 and the legislations prevailing at the time in the United States and the European Economic Community (EEC), the existence of four major legislations, together with their amendments and... 

The EEC had already in place the Coim-cil Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Many of the requirements under Coimcil Directive 65/65/EEC had already formed part of the Medicines Act. When Directives 75/318/EEC and 75/319/EEC were adopted by the Council of Ministers on 20 May 1975, they only supplemented and amended the original Directive 65/65/EEC. Therefore, when the United Kingdom joined the EEC in 1973, the provisions of these two new Directives did not substantially affect the licensing system that operated in the United... 

Kingdom under the Medicines Act, although certain relatively minor amendments were necessary. 

Under section 6 of the Medicines Act 1968, the Licensing Authority (LA) is the authority responsible for the grant, renewal, variation, suspension and revocation of licences and certificates. In 1971, the LA was constituted of a body of Ministers consisting of the Secretary of State for Social Services, the Secretary of State for Scotland, the Secretary of State for Wales, the Minister of Health and Social Services for Northern Ireland, the Minister of Agriculture, Fisheries and Food and the Minister of Agriculture in Northern Ireland. 

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