Brokerage in wholesale of medicinal products and active ingredients
Brokerage in medicinal products or substances or both are activities related to the sale or purchase of medicinal products or substances or both, except the wholesale trading which excludes contact with the substance or medicinal product and represents an independent brokerage on behalf of another business entity.
Agents in wholesale medicinal products and substances must:
- meet the requirements of good distribution practice for activities referring to brokerage;
- establish a traceability system for medicinal products or substances which enables support for the recall of a medicinal product or a substance;
- keep suitable documentation on the placement of medicinal products and substances;
- maintain a quality system, with clearly defined responsibilities and described procedures and a described method of risk management referring to relevant activities;
- ensure that medicinal products subject to placement have marketing authorisations or exceptional temporary marketing authorisations;
- verify and cooperate only with providers of medicinal products (manufacturers, importers, wholesalers) who meet the requirements of good manufacturing or distribution practice and operate in accordance with the regulations governing medicinal products or substances;
- inform the competent authority about counterfeits or suspected counterfeiting of medicinal products or substances immediately they become aware of the aforementioned, and
- keep documentation on the brokerage of medicinal products or substances which is available to the competent authority for inspection and store it for a least five years.
Conditions and evidence
- Status and registration Entry in the register of agents selling medicinal products and substances Organisation operates in accordance with the principles of good distribution practice Established traceability system of medicinal products/substances Keeping documentation on the placement of medicinal products/substances Maintenance of the quality system Verification of marketing authorisations Business cooperation only with suitable providers of medicinal products Informing on counterfeits or suspected counterfeiting of medicinal products/substances
Last updated: 18. 12. 2015