European Commission has issued a guidance on Good Distribution Practice (GDP) of medicinal products for human use. Indian pharma companies see the new norms would transform the pharma marketing in the region.
“We will now need to ensure that all drugs to be exported to the European Union will need to adhere to the new norms of European Commission. The fact is that most of us are on course,” said pharma companies like Biocon, Micro Labs and Dr. Reddy’s have already ample trade presence in the region.
The new guidelines replace the guidance on GDP of medicinal products for human use, published on 1 March 1994 (1) and the Guidelines of 7 March 2013 on GDP of medicinal products for human use. These Guidelines are now already enforced since its publication in the Official Journal of the European Union early this month.
The guidelines are based on Article 84 and Article 85b (3) of Directive 2001/83/EC (1). The revised guidelines were published in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union.
The version corrects factual mistakes identified in sub-chapters 5.5 and 6.3 of the revised guidelines.
The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today’s distribution network for medicinal products is increasingly complex and involves many players. The norms lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these rules will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products, said the regulatory authority.
According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products covers all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned.
Now the European Commission has classified the guidelines to focus on quality management, personnel, premises, equipment, documentation, operations covering qualifications of suppliers, complaints, , outsourced activities and transportation.
The regulator said that any person acting as a wholesale distributor needs to hold a wholesale distribution authorization. Further, the distributors must have suitable and adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products In particular, the premises should be clean, dry and maintained within acceptable temperature limits.
Possession of a manufacturing authorization includes permission to distribute the medicinal products. Therefore even manufacturers performing any distribution activities with their own products required to comply with GDP.
The wholesale distribution did not depend on whether the distributor is established or operating in specific customs areas, such as in free zones or in free warehouses. All obligations related to exporting, holding or supplying also apply to the distributors. Relevant sections of these guidelines should also be adhered to by those involved in the distribution of medicinal products.