Registration of medicines

Registration of medicines to ensnre that only safe efflcacions medicines of good qnahty are available in the market and that nnsafe non-efficacions medicines are banned... 

The registration of medicinal products is governed by relative values which cannot be clearly defined or limited, for example by ethical considerations and the endeavour to ensure the best possible quality and safety of pharmaceuticals. What is possible and achievable, may soon become a standard by which subsequent products will be measured. This leads to continuous and desirable improvements, but since there is no limit, very costly and undesirable extremes may be another consequence. According to today s standards, the most successful and beneficial pharmaceutical products, such as the vaccinia virus vaccine, live poliovirus vaccine and other live vaccines, would probably not be registrable for a wide-spread use in humans. 

Article 2 indicates that the Secretariat of the Medicines Commission (defined by Article 14 of the Royal Decree of July 3, 1969 on the registration of medicinal products) has to transmit within 5 days to the Transparency Commission ... 

Royal Decree of July 3, 1969 concerning the registration of medicines... 

Table 3. Registration of medicinal produces following EU centralized procedure.

National Requirements for Registration of Medicinal Products Following EU Centralised Procedure ... 

MINISTRY OF HEALTH REGULATION No. 17 of 9 June 1995 (as amended) on the Requirements to the Documentation for the Registration of Medicinal Products... 

For the registration of medicinal products, the persons specified in para 4 of Article 17 of the Law of Medicinal Products and Pharmacies in Human Medicine (State Gazette No. 36 of 1995), hereinafter referred to as the Law , shall submit to the National Drug Institute at the Ministry of Health an application form in two copies as specified in Annex No. 1. 

For products which contain less than one part per 10,000 of the mother tincture source extract or less than 1/ 100th of the smallest dose used in allopathy with regard to active principles, the complete documentation required for the registration of medicinal products shall be submitted. 

For renewal of the registration of medicinal products in pur-sutmce of para 1 of Article 31 of the Law, the manufacturer shall submit an application as per Annex No. 1, the administrative and the chemical and phcumaceutical parts of the dossier required for the respective medicinal product. 

Documentation for Registration of Medicinal Plants and Herbal Preparations... 

The centralised system is the procedure for registration of medicinal products derived from biotechnology, known as List A products, and for non-biotechnology products of an innovatory nature, known as List B products. 

The NIP S structure and activities are mostly dedicated to the registration of medicines and paramedicines. The NIP has biomedical and quality evaluation divisions with adequate laboratories, GMP, GLP and GCP inspectorates, adverse event monitoring, utilization and information sections, independent sections for registration, radiopharmaceuticals (the latter with laboratories), authorization of compassionate use of nonregistered medicines on an individual basis and pharmacy methodology. 

For homeopathic products without indication it is not necessary for the MA to prove efficacy. However, these products have to satisfy all of the other conditions of quality and safety. The same registration procedure is applicable for these products as for medicines. Other homeopathic products have to comply with the Decree on the registration of medicines the difference is that it is not necessary for the registration files to include pharmacological, toxicological and cliniccd tests. 

Reijnders, P. J. M. 1993. Registration of Medicines in The Netherlands. The Regulatory Affairs Journal. 4 196-199. 

The Licensing Authority is further advised by two expert committees on matters pertaining to the registration of medicinal products. They are the Medicines Advisory Committee cind the Quality Control Advisory Committee. 

To advise the Licensing Authority on the registration of medicinal products and any other matters relating to the Medicines Act and... 

Many importing countries require proof of registration of medicinal products in the country of origin before sales are permitted. To assist local manufacturers with export markets, the National Pharmaceutical Administration issues Certificates for Exporter of Medicinal Products to holders of product licences whose locally manufactured products conform to required standards of quality (See Appendix 7). The WHO format is used. 

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. 

In Switzerland health controls are largely a cantonal responsibility including healthcare systems, hospitals, professional education and the registration of medicines. In exceptional cases differences can exist, for instance, in the prescription status of individual pharmaceutical products from canton to canton (these are more the exception than the rule, however). To avoid duplication of effort and conflicting advice, the responsibility for pharmaceutical registration lies with the national regulatory authority, the Intercantonal Office for the Control of Medicaments (Interkantonale Kontrollstelle fiir Heilmittel or IKS). 

IKS Guidelines concerning the documentation requirements for the registration of medicinal products for human use. Registration Guidelines. 16 December 1977. Update 14 May 1998. IKS. Berne, Switzerland. 

Referring to Law No. 85-91 dated 22 November 1985, regulating the manufacture and the registration of medicinal products for human use and all texts amending or completing it ... 

Audrey G. Solodarenko is the Medical Director for the Rhone-Poulenc Representative Bureau in Kiev. He received his MD from the Ukrainicin Research Institute of Neurosurgery, both in Kiev. Dr. Solodarenko is responsible for relations with Ukraine s drug authorities in his capacity as Medical Director. His expertise is on the registration of medicinal products zmd the organization of clinical drug trials. He has written a number of scientific research articles. 

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