Farmatec will register API companies and brokers in the Netherlands. API stands for active pharmaceutical ingredients, the active substances in medicine for human use.
In the European Union, falsified medicine is increasingly available in the legal circuit. This is medicine of which the identity, history or origin has been falsified. falsified medicine is often made available via pharmacies. This medicine contains either sub-standard or falsified ingredients, no ingredients at all or the wrong dosage of ingredients. For this reason, they constitute a threat to public health. To combat this problem, a new European directive was adopted on 8 June 2011: Directive 2011/62/EU .
To whom does the obligation to register apply?
For manufacturers, importers and distributors of APIs an obligation to register will apply in the future (see Article 52(2) of the directive). These companies must contact Farmatec and indicate which active ingredients they use and which actions/activities take place.
For brokers in medicine an obligation to register will apply in the future (see Article 85(3) of the directive). Only persons registered with Farmatec may act as brokers in medicine. Acting as an broker in medicine is any activity in connection with the sale or purchase of medicine, with the exclusion of wholesale distribution, where there is no physical contact with the medicine. This consists of negotiating independently on behalf of another natural person or legal entity.
The Directive entered into force on 2 January 2013 and is currently being implemented in Dutch legislation. At present, the relevant amendments to the Medicines Act (Geneesmiddelenwet) and the Medicines Act Regulation (Regeling Geneesmiddelenwet) are being prepared. In principle, a directive only applies once it has been ‘translated’ into national legislation. That means that there are currently no registration requirements for dealers in APIs and brokers in the Netherlands.
However, in anticipation of the entry into force of the amendment to the Medicines Act and the Medicines Act Regulation, our method is as follows. We will give you the opportunity to notify us of your activities in advance. If you agree, we will then record your name and address details as API dealer or as a broker on www.farmatec.nl.
If you would you like to make use of this option please send an e-mail to firstname.lastname@example.org, including the name and address details of your company and indicate whether you agree to us recording this information on farmatec.nl. We also request you to send a current extract from the Trade Register of the Chamber of Commerce.
The preliminary record on our website has no legal effect and no further rights or obligations can be derived from it. After receipt of your e-mail, we will confirm this and inform you, if applicable, that your data has been recorded on www.farmatec.nl. At such time as further developments in this respect have taken place, the information on this website will be updated. If you have additional questions, please send these to email@example.com.