Sampling and testing: questions and answers

The European Medicines Agency (EMA) has published questions and answers on its sampling and testing programme.

For an overview on the programme and more details, see Sampling and testing.

1. How is the sampling carried out?

One of the aims of the programmes is to monitor the quality of the finished products in all part of the distribution chain throughout the authorised shelf-life, to check their compliance with the authorised specifications.

The staff that has the responsibility to take the samples (normally Inspectors of the national competent authorities), whenever possible will endeavour to have access directly to the products available in the pharmacies (community or hospitals pharmacies) - or at the wholesalers.

2. How many units of product are sampled?

The European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe decides on he exact number of units (tablets, vials, bottles, etc.), based on the parameters that need to be analysed.

Samples are normally taken from 3 different countries of the European Economic Area.

3. Who pays for the product sampled?

A voucher system has been implemented, and vouchers are provided (through EDQM) by the marketing authorisation holder to the inspectors.

The vouchers are exchanged at the point of sampling for the products.

The vouchers will then entitle to obtain from the manufacturer a quantity of product that corresponds to the units sampled.

4. Who analyses the medicines?

Testing is carried out in the laboratories of the official medicines control laboratories (OMCLs) network.

Normally one laboratory is involved in the testing of chemical products and two for biological products.

The laboratories are chosen on the basis of their competency, expertise and equipment.

5. Are all centrally authorised products tested?

EMA selects centrally authorised products for testing following a risk-based approach.

Human medicines that are subject to official batch release (e.g. blood products and vaccines) are excluded from this exercise - and products that are not yet available on the European market.

6. What happens after testing has been completed?

Testing reports are prepared by the EDQM and are sent on an on-going basis to EMA.

EMA forwards each report to the product's rapporteur and the co-rapporteur who, on the basis of the results, will decide on the action(s) to be taken.

A copy of the report is sent to the marketing authorisation holder for comments.

7. What happens if a product fails?

In the most serious cases, this could lead to the withdrawal of the product from the market.

In most of the cases, however, the problems identified during the testing can be dealt with by further investigations (e.g. inspection at a manufacturing site, seeking clarification from the marketing authorisation holder).

A specific EMA procedure is implemented to deal with products whose testing has highlighted quality problems or technical issues.

8. How are the programmes paid for?

Every year, the marketing authorisation holders pay EMA an annual fee to maintain the marketing authorisation. Part of these fees is used for the implementation of the programmes.