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A Study On Drug Authorization In Turkey For The Period Of 1982-2001
Gülbin ÖZÇELİKAY*
* Doç.Dr., Ankara Üniversitesi Eczacılık Fakültesi, Eczacılık İşletmeciliği AD, ANKARA
In Turkey, it is necessary to get marketing authorization from the Ministry of Health for production, export and import of drugs. Before giving authorization, the evaluation of drugs are carried out according to the international drug norms by the scientific committees appointed by the Ministry of Health. These committees examine the drugs in terms of security, quality and efficacy. In Turkey, the validity of drug authorizatons are unlimited unless they cancelled by the Ministry of Health and all applicants can take drug autorization according to the Law Concerning Pharmaceuticals and Medical Preparations No 1262.
In this study, production authorizations given by the Ministry of Health have been examined according to their pharmacutical forms and producers for the period of 1982-2001. On the other hand drug forms and the number of drug authorization in last 20 years was compared with those in period of Ottoman.
The materials of this study are the drug authorization by the Ministry of Health in last 20 years and the laws and Regulations related with drugs and Pharmacy.
In conclusion, total 78 of drug authorization were given in 1982. 22 of these are in tablet forms. The number of authorization reached to 287 in 2001. 156 of them are import drug authorization.Keywords: Drug authorization, Ottoman Period, Ministry of Health, Law
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