marketing authorisation via centralised procedure

In the Netherlands, medicinal products can obtain marketing authorisation via a national procedure. But alongside the national procedure there is also a European route to marketing authorisation valid throughout the European Union. This route is referred to as the centralised procedure. Marketing authorisations are granted under the responsibility of the European Commission. The main advantage of this procedure is that new, innovative medicinal products can be made available to all European residents at the same time once marketing authorisation has been granted. The centralised procedure also leads to greater efficiency in Europe, as only one or two member states are asked to produce assessment reports for each medicinal product.

Procedure
Pharmaceutical companies wishing to follow the centralised procedure submit a dossier to the European Medicines Agency (EMA) in London. The dossier is assessed by the scientific committee of the EMA, the Committee for Medicinal Products for Human Use, or CHMP for short. The CHMP is one of the EMA's scientific committees. It has up to 210 days to reach a final decision. This period may be suspended to allow the company to answer questions. Companies can also give verbal explanations relating to the dossier they have submitted. The CHMP produces an opinion which is sent to the European Commission and used in reaching the final decision. The European Commission usually adopts the CHMP's opinion in all respects.

Once a favourable decision has been made, the Summary of Product Characteristics and the package leaflet are written. A European Public Assessment Report (EPAR) is produced. If the opinion is negative, information is given as to the grounds on which this conclusion was reached. This can be found at the EMA's website (http://www.ema.europa.eu/)

Products that have obtained marketing authorisation via the centralised procedure are given a European marketing authorisation number.

Certain products must undergo the centralised procedure: medicinal products that have been made using biotechnology, and new medicinal products intended to treat cancer, AIDS, neurodegenerative diseases and diabetes. In the case of other innovative products, companies are free to opt for either centralised or national registration.

EMA/CHMP

The European Agency for the Evaluation of Medicinal Products (EMA), based in London, receives applications under the centralised procedure and controls the assessment process.

CHMP
The Committee for Medicinal Products for Human Use (CHMP) sits in London and is the scientific committee which discusses the medicinal products. The CHMP submits an opinion to the European Commission which then comes to a binding decision. Each European member state has one representative on the CHMP and one alternate. Two rapporteurs are appointed in the CHMP for each medicinal product, and they monitor the product throughout its life cycle. CHMP members operate in their personal capacity. They act as a bridge between the European system and national systems. In the Netherlands, the Dutch CHMP member reports to the Medicines Evaluation Board.

Scientific Advisory Groups (SAG)
An SAG is made up of a core group of six to eight experts in a particular therapeutic field. Other experts may be appointed where necessary. The CHMP can ask a SAG to advise on the assessment of a particular product, for example on how a certain patient group can be identified or whether measures aimed at limiting risk are feasible. There are currently six SAGs. The CHMP can also ask experts for advice on an ad-hoc basis.

CH MP working parties
The CHMP is assisted in its work by a number of permanent and ad-hoc working parties. Examples include:

• Safety Working Party (preclinical)
• Pharmacovigilance Working Party (monitoring medicinal products)
• Efficacy Working Party (clinical aspects)
• Quality Working Party (chemical and pharmacological aspects)
• Biological Working Party (ditto for biological products)

The Medicines Evaluation Board is normally represented on all working parties.

Notes for Guidance
These are CHMP guidelines based on reports from the working parties on topics such as indications. The Notes are submitted to the CHMP for approval. Once the member states and other interested parties have commented, the CHMP decides whether to adopt them. The Notes are a foundation stone of the harmonisation policy.