Medicines Control Council

South Africa controls the production of drug products (medicines) under the Medicines and Related Substances Control Act (Act 101 of 1965), which states that the Medicines Control Council may issue to a drug manufacturer a license to manufacture a drug product upon such conditions as to the application of such acceptable... 

Anonymous (2002), Medicines and Related Substances Control Act 101 of 1965, Medicines Control Council, available http //www.mccza.com/showdocument. asp Cat=27 Desc=Acts % 20and % 20Regulations. 

The regulatory authority in South Africa is the Medicines Control Council (MCC) (Council), a statutory body assisted by a secretariat/directorate, which also reports to the Minister of Health. Council policies are reflected in MCC Circulars and Council resolutions to applications cire reflected in Council letters to the specific applicants only. 

Act 90 of 1997 is the latest cmd most significant amendment to Act 101 of 1965. The purpose of Act 101 of 1965 is to provide for the registration of medicines intended for humcin and animal use, the registration of medical devices, the establishment of a Medicines Control Council, to schedule substances cmd medical devices and for matters incidental thereto. 

Recent policy decision by the Medicines Control Council Child protective measures... 

Recent policy decisions by the Medicines Control Council A5/80 Medicines Control Council Proposed policy... 

Professor Johann Schlebusch is a pharmacist who has been involved in medicine regulatory affairs since 1972. He has extensive experience as an assessor of GMP and QA, and wcis responsible for the assessment of modifications and changes to the quality part of the medicine registration application. He was the Registrar of Medicines from 1983 to 1998 and Director of the Directorate (secretariat) of the Medicines Control Council for the same period. 

Guidance document good manufacturing practice for medicine in South Africa. South Africa, Medicines Control Council, 2003. 

The content of this Guide is addressed to the manufacturers of ethical and proprietary medicines. The Guide has, however, no legal standing. The responsibility for GMP lies with the individual company to comply with Act 101 of 1965 as amended and to satisfy the Medicines Control Council during plant inspections. Nevertheless, companies may impose stricter in-house standards. Alternative measures capable of achieving the requirements are also acceptable. 

A description of the manufacturing facility, including a company profile plus a description of the premises, equipment, personnel and standard operating procedures relating to manufacture and the quality system. This must lodged with the Medicines Control Council. 

Medicines Control Council Ministry of Health and Social Services P.B. 13366 Windhoek... 

Medicines Control Council Private Bag X828 Pretoria 0001 Tel 2712 312 0322 Fax 27 12 326 4344... 

Regulation of medicines in Zimbabwe started in 1969, with the promulgation of the Dmgs and Allied Substances Control Act, Chapter 320. This Act created the Dmgs Control Council (a body corporate), which started operations in 1971. The 1997 amendment transformed the Dmgs and Allied Substances Control Act into the Medicines and Allied Substances Control Act (MASCA), Chapter 15 03, which established the Medicines Control Agency of Zimbabwe (MCAZ), with increased authority. 

Medicines Control Agency (MCA) Medical Matrix Medical Research Council MEDLINE (free)... 

The Medicines Control Act 101 of 1965 (the Act) and its comprehensive Regulations govern the control of medicincil products. Licenses to manufacture and register as a pharmaceuticcil concern are issued by the Pharmacy Council. This aspect is addressed in the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 (Act 90 of 1997) that must still become operational at an undisclosed date in the future. 

For (Juality Control purposes the required measurement uncertainty is set by the Official Medicines Control Laboratories (OMCL) Network of the Council of Europe. The measurement uncertainty for analytical weighing is... 

The first Venezuelan dmg law, the Ordinance of the Council of Physicians and Secret Medicines and Patents (1883), stated its objective as the control and registry of medicines, in order to develop a pharmacopoeia of dmgs with established pharmacological properties, composition, indication and dosage, for the purposes of standardization. A product registration system was developed and the DRA was created some decades later. 

The EP is published under the direction of the Council of Europe and is available in English and French. It is the result of obligations undertaken in a convention set up under the auspices of the Council of Europe and signed by 19 countries. The EP has two important aspects, the unification of national pharmacopoeia and the unification of methods of quality control of medicines. 

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. 

The production of drug products (medicinal products) in the European Union (EU) is controlled under Directive 2001/83/EC of the European parliament and of the Council, which states that the holder of a manufacturing authorization for medicinal products is obliged to comply with good manufacturing practices as laid down by European Community law [13]. The principles and guidelines of GMP for medicinal products are stated by the Commission directive 2003/94/EC, which provides the... 

National Council on Alcoholism and Drug Dependence and the American Society of Addictive Medicine defines alcoholism as a chronic disease influenced by genetic, psychological, and environmental factors. Alcoholism is described as a loss of control over drinking—a preoccupation with drinking despite negative consequences to one s physical, mental, and emotional makeup as well as one s work and family life. 

Nordic Council on Medicines. (1989), Radiopharmacy Preparation and Control of Radiopharmaceuticals in Hospitals, NLN Publications No. 26, Uppsala, Sweden. 

This is a joint project between the EU and the Council of Europe to allow the coordination of laboratory controls between the EU and BETA members. In 1999, a contract was signed between the EMEA and the EDQM to organize sampling and testing of centrally authorized medicinal products by the OMCL network. 

In recent years, the European Pharmacopeia Commission has elaborated a policy of replacing the use of animals in quality control testing of medicines in parallel with the application of the corresponding Convention of the Council of Europe. A sizeable program has been set up to apply the 3-R concept (refine, reduce, replace). To this end, the Council of Europe, represented by the EDQM, and the Commission of the European Communities are now working on an extensive standardization programme to set up collaborative studies to ... 

According to Regulation No. 21, the advertising control is performed a priori and is organized according the Council Directive 92/28/EEC. The approval is usucilly obtained by the NDI in less than one month. The fees are about US 6 for printed advertising material and US 10 for audio-visual advertising. The approval is Vcilid for the period stated by the MA of the medicinal product advertised. 

---