Our core business

The FAMHP is the competent authority in the domains that touch upon the different phases of the life cycle of medicines and health products.
Our main activities focus on all medicines and health products for human and veterinary use and can be divided into four main domains.

Advising all our partners, starting from our expertise:

• national, European and worldwide authorities;
• policy makers such as the parliament and the minister in charge;
• the academic world;
• the industry;
• healthcare professionals;
• the press;
• patients and citizens who require further information.

Delivering official documents such as authorisations, approvals, certificates. For example:

• clinical trial approval;
• marketing authorisation (MA);
• authorisation for parallel import;
• standardisation of pharmacy made preparations and monograph approval;
• authorisation of raw material for pharmacy made preparations;
• notification number or export certificate;
• approval of advertising to the general public and visas for scientific events;
• authorisation for production an import (MIA) or for wholesale dealer (WDA);
• certificate for pharmaceutical product;
• authorisation  for the establishment, transfer or registration of a retail pharmacies;
• authorisation for certain activities or for the import or export of narcotics and psychotropic substances or drug precursors;
• accreditation for human tissue material organisation.

Watching over the quality, safety and efficacy:

• ensuring follow-up of assumed adverse reaction and incident notifications with medicines and health products, evaluating these notifications and taking the necessary corrective actions;
• organising control activities and surveys;
• carrying out inspections and controls;
• ensuring follow-up of the quality problem notification system for medicines.

Imposing sanctions such as:

• imposing an administrative penalty;
• withdrawing or adapting official documents;
• taking health protecting measures;
• imposing a ban.