Authorisation, Registration, and Risk Monitoring of Medicinal Products
Since 1978, finished medicinal products have been required to undergo an authorisation procedure before they can be placed on the market. The pharmaceutical companies must provide proof of the pharmaceutical quality, efficacy, and safety of the product. If they fail to do so the BfArM refuses authorisation.
After a period of 5 years, marketing authorisation must be renewed by the BfArM. Renewal of authorisation will be granted provided the pharmaceutical company files an application for renewal in due time and a new review shows that there are no objections.
Variations to already authorised medicinal products have to be notified to the BfArM. Significant variations to medicinal products may be implemented after authorisation by the BfArM only.
Homoeopathic medicinal products only need to be registered, provided that no indication claims are made for them and that adequate quality is demonstrated. If indication claims are made the homoeopathic medicinal product has to be authorised. The BfArM is also involved in authorisation procedures for medicinal products in the European Union.
According to Section 55 German Medicines Act (Arzneimittelgesetz AMG) reference can be made to the pharmacopoeia in the course of authorisation of finished drugs and registration of homoeopathic medicinal products. This serves as a relief to both industry and authorities. The pharmacopoeia is a collection of quality specifications which is continuously updated and consists of the German, the European, and the Homoeopathic Pharmacopoeia. The European Pharmacopoeia contributes considerably to the international harmonisation of quality specifications.
If a medicinal product is marketed after authorisation and is used by many patients, rare adverse effects may be detected which had not attracted attention before. The BfArM collects and verifies such reports forwarded by German physicians and pharmaceutical companies. The BfArM decides whether the SPC and the Package Leaflet need to be changed in order to allow for such risks. Should identified adverse effects of a medicinal product prove to be severe or occur frequently so that they exceed the benefit the BfArM withdraws the license. In the course of determination, evaluation, and prevention of drug-related risks the BfArM communicates constantly with other European authorities and the World Health Organisation (WHO).
Apart from the national authorisation procedures in Germany, new authorisation procedures have been created on the basis of regulations and directives of the European Commission. A Centralised Procedure (CP) effects a license throughout the EU. In order to obtain a license within more than one EU country at the same time the applicant has to initiate a so-called “Decentralised Procedure” (DCP) or apply for a “Mutual Recognition Procedure” (MRP).
National Authorisation Procedures
In Germany, finished medicinal products are only to be put into circulation after having been authorised (Section 21 sub-section 1 German Medicines Act, AMG) or registered (Section 38 sub-section 1 AMG respectively Section 39a AMG) by the competent higher federal authority.
The competent authority for human medicinal products is the BfArM, while sera, vaccines, test allergens, test sera and test antigens as well as blood preparations are the responsibility of the Paul-Ehrlich-Institut (PEI) in Langen. Veterinary medicinal products are authorised by the BVL (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit) (Federal Agency of Consumer Protection and Food Safety) in Bonn.
In order to apply for a marketing authorisation for a finished medicinal product the appropriate application form is to be used:
Summary of the dossier / New forms for the Application for Marketing Authorisation of a Medicinal Product at the Bundesinstitut für Arzneimittel und Medizinprodukte or at the Paul-Ehrlich-Institut/Bundesamt for Sera and Vaccines (date: 15.05.2003)
The necessary forms and annotations to the application as well as the text of the German Medicines Act can be obtained from the Bundesanzeiger-Verlagsgesellschaft mbH, Postfach 10 05 34, 50445 Köln, the latter is also available at bookshops.
Centralised Authorisation Procedures
In this type of procedure, authorisation of medicinal products is not granted by a national agency but by the European Commission in Brussels. The organisational process is handled by the EMEA in London. The submitted documentation is reviewed by the scientists from the licensing agencies of the EU Member States, among them those of the BfArM.
Decentralised Authorisation Procedures
If a medicinal product has not yet been marketed in any EU Member State it may be recognised by the licensing authorities of other Member States within 210 days. Thereafter, the authorisation will be granted unless one of the CMS determines “serious risks to public health” for the medicinal product.
Mutual Recognition Procedures
The marketing authorisation already granted by one EU Member State is to be recognised by the licensing agencies of other Member States within 90 days, unless there are major objections against doing so. The short review periods place a great demand on all those involved in the procedure.
|Further information: Changes due to the restructuring of the BfArM as of 1 July 2005|