Regulatory Representation
Your local regulatory partner for the European market
We facilitate access of your products to the European market, assuming the mandatory legal and regulatory representation before the competent authorities, ensuring ongoing regulatory compliance.
Do you need regulatory representation in another sector? Tell us your situation. The first consultation is free. Let's talk →
Local Representative for Medicines
What is a local representative and why is it needed?
A local representative for medicines is the natural or legal person designated by the Marketing Authorisation Holder (MAH) of a medicine to act on its behalf in Spain, pursuant to Art. 2 of Royal Decree 1345/2007.
This legal figure serves as the official and technical point of contact between the MAH or pharmaceutical laboratory and the local health authorities of the country, such as the AEMPS in Spain.
What does Fartell do as a local representative?
We act as local representative in Spain for MAH laboratories located in member states before the AEMPS to ensure the continuity and expansion of your business.
Fartell serves as
Official point of contact
Official and technical/legal liaison with local health authorities.
Variations and renewals manager
Manager of variations, renewals and supply shortage notifications (maintenance of registration in Spain).
Pharmacovigilance manager
Local manager for receiving and reporting suspected adverse reactions (pharmacovigilance).
Client profile
Is this service for your company?
Companies that need to hire a local representative for medicines are generally foreign pharmaceutical laboratories that wish to sell their medicines in Spain without needing to open a physical subsidiary or their own regulatory structure.
This service is essential for
Frequently asked questions
Frequently asked questions about local representation
Does your company want to commercialise medicines in Spain?
Tell us your situation and we will explain how we can act as your Local Representative in Spain. The first consultation is free.
Do you need regulatory representation in another sector?
Tell us your situation. The first consultation is free.