Is it necessary for a manufacturer of medicinal products to comply with the Good Distribution Practices (GDP) or is this the task of the wholesalers and distribution companies?
>> GDP requirements are very similar to the requirements stated in the GMP for manufacturers in relation to storage of medicinal products. Manufacturers must comply with the product storage requirements as stated in the GMP. Iin addition, if they are responsible for the distribution of their products, they also need to follow the GDP requirements; these include storage and transportation of their products in line with the product label, ensuring its safety and security throughout the supply chain.
According to Chapter 2, paragraph 2.2. each wholesaler needs to designate a person as Responsible Person for GDP. Are there any circumstances in which the manufacturer of the medicinal product needs to designate a Responsible Person?
>> The EU Manufacturing authorization includes the wholesaler’s license, therefore a manufacturer can legally distribute its products, the QP named in the Manufacturing License can take the responsibility for storage and distribution of the product. As a consequence, there is no need for the manufacturer to name an RP. However, depending on the organization structure and the complexity of the operation, the company may appoint a person responsible for product distribution.