EAEPC and all its members are committed to the highest level of safety and quality. In 2005, taking account of its responsibility in the repackaging and handling of products related to public health, the EAEPC developed a comprehensive code of conduct for all its members to follow. This document is known as the EAEPC Good Parallel Distribution Practice Guidelines for Medicinal Products (EAEPC GPDP Guidelines) in abbreviation.

Compliance is a condition of membership for all parallel distributors affiliated to EAEPC. The GPDP Guidelines are based on the EU Good Distribution Practices rules developed by the European Commission.

Parallel distributors are an established component of the distribution process in Europe for medicinal products for human use. As such they follow exactly the same manufacturing and distribution regulations as other market players, including multinational companies.

The full code of conduct can be accessed here.

Safety is EAEPC’s top priority. Whilst all parallel-distributed medicines are already subject to the rigorous EU approval process before being first sold on the EU market, parallel distributors must obtain from the same competent authority which authorized the original product a simplified marketing authorisation for the product to be distributed in parallel. As part of this process, the pack labelling and patient package leaflet of the parallel-distributed product undergo a linguistic compliance check with the nationally (or centrally) approved equivalent product.

Parallel distributors are required to hold a pharmaceutical wholesaling authorisation are obliged to follow Good Distribution Practice (GDP) guidelines in accordance with Article 84 of the Directive 2001/83/EC.

As a manufacturing operation, all repackaging/re-labelling activity requires a pharmaceutical manufacturing authorisation issued by the competent authority in the country of destination. Holders of manufacturing authorisations are obliged to follow Good Manufacturing Practice (GMP) guidelines, employ an EU Qualified Person and are subject to periodic inspection by the competent authority.

Finally, the parallel distributor in the country of destination has to adapt the packaging/labelling of every incoming batch to access the local market, in accordance with the marketing authorisation, national law and decisions of the ECJ.

To ensure the highest standards of safety and quality, EAEPC’s code of conduct focuses on the following steps:

  1. Maintenance of the integrity of the supply chain - Parallel distributors only purchase medicinal products with marketing authorisations from authorised EU wholesalers or manufacturers in other EEA countries. Parallel distributors only sell or supply medicinal products with marketing authorisations to authorised wholesalers, registered pharmacies or other persons entitled to sell medicinal products to the general public.
  2. EU Qualified person – specially trained employee(s) to ensure that a pharmaceutical quality system is implemented and maintained.
  3. Control of incoming stock - Each incoming lot must be checked against the marketing authorisation and an authentic reference sample of the product received from the source country.
  4. Re-labelling / Repackaging - re-labelling is undertaken in accordance with the national simplified marketing authorisation of the parallel-distributed product. This either involves replacement of the original outer carton with a brand new one or over-stickering the original outer carton, with both providing the approved label text in the language of the country of destination, as well as a new patient information leaflet, as approved in the destination Member State.
  5. Final Release - No product may be sold or supplied to the market by a parallel distributor until its relabelled/repackaged batch is released by the Qualified Person.
  6. Storage conditions - Medicinal products must be stored apart from other goods, in clean, safe and secure areas, and under conditions specified by the manufacturer, the marketing authorisation and the wholesale authorisation.
  7. Transport conditions - Conditions for the transport of stock must be in accordance with GDP and in compliance with the requirements for each individual product.
  8. Inspections - Regular GMP inspections are undertaken at parallel distributors (performing re-labelling/repacking activities as described above) by the competent authority in the member state concerned to ensure that EU GMP Volume 4 is adhered to. As wholesalers, all parallel distributors are also subject to regular GDP inspections by the competent national or regional authority.

For more details and the full code of conduct please click here