Líder en el mercado de Productos de Distribución Europea
With a vade mecum of more than 170 references that include medicines, health products and parapharmacy. More than 2,500 pharmacy offices trust us.
We are backed by more than 20 years of experience in the sector, forming part of a multinational group with a presence in Germany, France, Netherlands, England, Italy and Portugal.
This is our current team,
always on the lookout for new talent
Corporate Social Responsibility
We now repackage and produce locally in Barcelona, and have digitalized order processing for the entire Spanish pharmaceutical market.
Philippe Ollivier, Dir.gral. Difarmed. 2022
What is a European Distribution Product?
European Distribution or parallel importation means that a medicinal product authorised in one member state can be marketed in another member state, in which it is also authorised.
To do so, it is necessary to obtain a Parallel Import Authorisation (AIP), granted by the AEMPS or EMA, in the case of a speciality with a European registration.
This authorisation can be obtained as long as the quantitative and qualitative composition, the pharmaceutical form and the therapeutic effects of the imported product are identical to those of the product previously authorised by the competent agency.
The PDEs have a national code different from the national presentation code assigned by the AEMPS, and the product will be re-packaged according to the regulations of the country of marketing.
The relabelling or repackaging of a parallel imported speciality depends on the characteristics of the outer packaging of the medicinal product, the requirements of the health authorities and the trademark rights holder.
In order to meet optimal quality standards and to ensure the safety and traceability of EDPs, Difarmed strictly applies Good Manufacturing Practices and Good Distribution Practices.
Difarmed complies with the Delegated Regulation (EU) 2016/161 and the serialisation requirements from the outset, both with the unique identifier and the tamper-evident devices on the secondary packaging.
