Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Legislation around Wholesalers and Impact of new Developments of the EU GDP Guideline

Stephanie Gelsen (Abschlußjahr: 2012)

Summary

Language: English

The European legislative requirements for wholesalers are laid down in Directive 2001/83/EC Title VII and in the EU GDP Guideline 94/C 63/03. These legal requirements are now under review: the Directive 2001/83/EC has recently been modified by the Directive 2011/62/EU and will come into force on 2nd January 2013 and the GDP Guideline is redrafted and under revision after a public consultation (SANCO/C8/AM/an D(2010)380358).

In Germany, the Medicinal Product Act (AMG) § 4 section 22, § 47, § 44, § 43 and § 52a,b, the Ordinance on Internal Regulations for Pharmaceutical Wholesalers (AMGrHdlBetrV) and the Ordinance on the Production of Medicinal Products and Active Substances (AMWHV) are the legal basis around wholesaling.

In order to implement the changes of Community legislation into national law, major amendments will be introduced with the 2nd Act to change German drug law and other regulations, which is also termed 16th Amendment to the AMG.

Until the 12th Amendment to the German Medicinal Product Act, a simple notification of wholesaling activities to the competent national authorities was sufficient. After that, in order to implement the requirements of EU Directive 2001/83/EC into national law, a wholesale authorization was the prerequisite for any further wholesaling activities. The conditions for granting of the wholesale authorization are described in detail in § 52a AMG.

Since the coming into effect of the 15th Amendment to the AMG the public service obligation are pointed out in § 52b AMG to ensure an adequate and continuous supply of medicinal products to the public. A new aspect introduced by the 2nd Act to change drug law and other regulations is the possibility for the authority to impose sanctions to wholesalers and pharmaceutical entrepreneurs when delivery agreements are not met in Germany.

One of the changes introduced by the 2nd Act to change drug law and other regulations to the AMGrHdlBetrV is that the name of this ordinance will be changed to Ordinance on the Trade with Medicinal Products ("Arzneimittelhandelsverordnung") to include the concept of broker according to Directive 2001/83/EC Art. 85b.

The number of wholesale authorizations in Germany is noticeable high in comparison to other European countries it amounts to 4000. For a pharmacist and a broker it is not allowed to possess a wholesale authorization according to their national law in most of the EU Member States. Once the Directive 2011/62/EU has come into force, the definition of wholesalers will apply to brokers in all Member States and they are obliged to register their operation of wholesaling activities. In this respect, the situation in Europe will be harmonized.

Significant innovations will be introduced by the new developments of the EU GDP Guideline. The revised GDP guideline will bring further demands with its requirements for wholesalers and for those who will become a wholesaler. High demands will be made in the near future on the Quality Management System in the GDP context. Special emphasis must be placed on the high workload of the Responsible Person with the requirement to be permanent available. A further demanding requirement is the qualification of each supplier before procurement and the periodic re-test. The new “bona fide” checking process used to verify that the supplying wholesale distributor meets GDP would add significant audit burdens. The most relevant requirements are found under the new chapter "Transportation". The guideline emphasizes that the storage condition as indicated on the packaging information should be kept through the entire transportation stage. The provision stipulates that the storage sites at transportation hubs need a wholesale distribution authorization when medicinal products are held for longer than 24 hours. In addition hubs holding refrigerated products must be licensed irrespective of the storage time.

The purpose of the great number of amendments in the legislation of wholesaling is to harmonize requirements in Europe. The main focus is transparency in the trade of medicinal products and the prevention of falsified medicines the purpose of all of this being the protection of patients.

Pages: 91, Annexes: 3 (pages: 7)