Which legal guidelines are the basis for the compliance check?

The document “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” is the legal basis for the ‘SAP R/3 GDP Compliance Check’. You can access this document  when you search for “(94/C 63/03)” on the internet.

Special attention is given to article 17 in the section ‘Deliveries to customers’, stating “Deliveries should be made only to other authorised wholesalers or to persons authorised to supply medicinal products to the public in the Member State concerned”. When translated into layman’s terms, the article says that medicine should only be delivered to those allowed to receive them.

In addition, the other articles focusing on delivering medicine are also taken into account as they specify documentation and transportation requirements.

Along with the date, also the description of the medicine, quantity supplied as well as the name and address of the supplier and addressee must be printed on the document that accompanies the delivery of medicine.
When transporting medicine, no contamination must take place and should not be subjected to unacceptable degrees of heat, cold, light and moisture. In addition adequate precautions are expected against spillage, breakage or theft.

 

Deliveries to customers

17.   Deliveries should be made only to other authorised wholesalers or to persons authorised to supply medicinal products to the public in the Member State concerned.

18.   For all supplies to a person authorised or entitled to supply medicinal products to the public, a document must be enclosed, making it possible to ascertain the date, the name and pharmaceutical form of the medicinal product, the quantity supplied, the name and address of the supplier and addressee.

19.   In case of emergency, wholesalers should be in a position to supply immediately the medicinal products that they regularly supply to the persons entitled to supply the products to the public.

20.   Medicinal products should be transported in such a way that :
a) their identification is not lost;
b) they do not contaminate, and are not contaminated by, other products or materials;
c) adequate precautions are taken against spillage, breakage or theft;
d) they are secure and not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influence, nor to attack by microorganisms or pests.

21.   Medicinal products requiring controlled temperature storage should also be transported by appropriately specialised means.

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