13/14 December 2023
Medicinal products are subject to special regulations for storage and transport. Good Distribution Practice (GDP) is the part of quality assurance that ensures that the quality of medicinal products is maintained at all stages of the supply chain.
However, GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport of the active pharmaceutical ingredients (APIs) used for production.
The "Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)" gives the following definition:
For APIs for veterinary medicinal products, there is an analogous definition in the "Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council":
Requirements for APIs for medicinal products for human use can be found in Chapter 6 of the EU GDP Guidelines. This chapter is divided into "Orders", "Receipt", "Storage", "Delivery to customers" and "Transfer of information". Of particular importance is that active substances should always be transported under the conditions specified by the manufacturer so that their quality is not affected.
In addition, the following applies:
The requirements for the transport of active substances for veterinary medicinal products are comparable to those for human medicinal products.
In accordance with Article 18 of Implementing Regulation (EU) 2021/1280, the APIs may only be supplied within the Union to other distributors, manufacturers, dispensing pharmacies or to persons permitted by national law.The following also applies: