Why is being tested?
Regular sampling and independent testing of medicinal products is required by national and European laws. Ultimately, it serves to warrant a high quality of the medicinal products on the market and therefore, the protection of the consumer.
The European legal basis is “Guideline 2001/83/EC on the Community code relating to medicinal products for human use”, which in Article 111 stipulates:
- “The competent authority of the Member State concerned shall … ensure that the legal requirements governing medicinal products are complied with … by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples.”
- Such inspections shall be carried out by officials representing the competent authority who shall be empowered to “… take samples including with a view to independent tests being carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by a Member State.”
The same wording can be found in Article 80 of the “Guideline 2001/82/EC on the Community code relating to veterinary medicinal products”.
The national basis is the German Medicinal Products Act (AMG). It stipulates in its § 64 (3) that the competent authorities shall “… also have medicinal product samples tested officially.”
The current versions of the guidelines and laws cited can be found on the homepage of the ZLG.
Who takes the samples and where are they taken?
The legal basis for sampling is § 65 of the AMG. According to § 5 of the administrative instructions of the German Medicinal Products Act (AMGVwV), the competent authorities in conjunction with the OMCLs set up an annual plan of the samples to be taken. This is done in cooperation between InphA and the competent authorities of the six member states. The sampling plan takes into account the sampling of medicinal products
- in the first year and then every subsequent five years after marketing authorisation has been granted
- with particular risk potential
for national or Europe-wide screenings.
What are planned samples, what are suspicious samples?
Sampling of so-called planned samples takes place according to the above sampling plan, by the competent authorities, either within the framework of the inspection of the pharmaceutical companies or from wholesalers, pharmacies or hospital pharmacies.
In addition to planned samples, in case of abnormality, so-called suspicious samples are taken either by the competent authorities or by, e.g. police, customs or public prosecutors. These are mostly samples, where there is doubt regarding the proper quality, where there is suspicion of counterfeiting or illegal import, or that are confiscated by law enforcement agencies during searches.