A Dutch importer, Adriaan de Peijper, was prosecuted for importing a medicinal product from a wholesaler in the UK without the approval of the Dutch authorities, and without possessing either the product marketing approval documents or the batch records. De Peijper argued that he was unable to provide such evidence because the manufacturer would not give him access to the necessary data. The product was authorised in both the Netherlands and the UK, and the Dutch court referred the matter to the ECJ.
The Court found in favour of the plaintiff; asking him to produce the records demanded by the Dutch authorities was held restrictive:
'National rules or practices which make it possible for a manufacturer of the pharmaceutical product in question and his duly appointed representative, simply by refusing to produce the documents relating to the medicinal preparation in general or to a specific batch of that preparation, to enjoy a monopoly of the importing and marketing of that product, must be regarded as being unnecessarily restrictive.'
The Court felt that as the relevant documentation was already held by one set of authorities, they should co-operate in making these available on a reciprocal basis, and that member states should develop a presumption of conformity. If the parallel-traded and the domestic versions were slightly different it was up to the authorities to investigate whether this was therapeutically significant.
The only measures which a national regulatory authority were justified in taking as regards parallel trade, the Court said, were those intended to verify that such products were identical with the version already marketed in that country by the domestic trade mark owner, or that the difference had no therapeutic effect.
Following the de Peijper judgement, the European Commission produced a text outlining the basic principles for an abbreviated form of marketing authorisation for parallel-traded medicines.
The Commission recommended that the information supplied by the importer should be sufficient to ensure that the medicine is covered by an existing authorisation in the country of destination. The parallel-traded version must therefore:
- contain the same active ingredient(s)
- be administered to patients through the same route
- have the same therapeutic effects
- have a common origin
It established that there is a minimum amount of information that the importer is required to provide, including
- the product name and where it is sourced
- the name and address of the holder of the full marketing authorisation, both in the member state of origin and in the member state of destination
- the name and address of the parallel trader
- the product's marketing authorisation number in the source country
- the product's summary of product characteristics
- specimens or mock-ups of the product in the form in which it will be sold in the member state of destination
The Commission also suggested a period of a maximum of 45 days for the authorities to assess an application. In reality this period is often very much longer.
- Parallel traders are required to keep records of the origin, quantity and batch numbers of all products they sell
- If they are involved in modifying the outer packaging to enable the product to enter the local supply chain they need a manufacturing authorisation, which involves periodic government inspection and the requirement to have substantial insurance cover
- In most countries it is also a requirement for importers to hold a wholesale dealing authorisation, as well as a manufacturing authorisation, if pharmacies are supplied directly. This involves implementing measures to ensure an audit trail for product traceability , maintaining suitable premises for the storage of medicines and the establishment of approved product recall procedures