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Regulatory News | 16 July 2015 | By Michael Mezher
To boost transparency for re-exported drugs, the European Medicines Agency (EMA) has created a new publicly available online register for parallel distribution notices.
Parallel distribution, often referred to as re-exportation, allows companies in the EU to distribute centrally authorized medicines between member states, independent of their marketing authorization holder. This practice makes it possible for cheap drugs in one Member State to be distributed to another where they can be sold for a profit.
Parallel distribution is allowed under European free-trade laws, and specifically for medicinal products under Regulation (EC) No 726/2004, which tasks EMA with:
"Checking that the conditions laid down in Community legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation."
And in Article 76(3) and (4) of Directive 2001/83/EC, which states:
"(3) Any distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of his intention to import that product.""(4) In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed."
"(3) Any distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of his intention to import that product."
"(4) In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed."
To distribute centrally authorized medicines in this manner, distributors must notify a product's marketing authorization holder and EMA, which will then review the request and verify that the distributed product, as well as its label and packaging, meet the requirements of the destination Member State.
Previously, EMA would publish the notifications it received for parallel distribution requests on a monthly basis. However, with the number of notices in the thousands each year, this method of publishing was difficult to keep track of for both regulators and companies involved in the process.
By moving parallel distribution notices to a new publicly available online register, EMA says it will be easier for national regulators, distributors, pharmaceuticals manufacturers, patients and healthcare professionals to keep tabs on what products are being distributed in this manner.
EMA says the register currently holds more than 15,000 notices and will continue to be updated monthly. Anyone interested in searching for a parallel distribution notice can do so by searching the register by product name, strength, packaging size, pharmaceutical form, EU number, marketing authorization holder and/or parallel distributor.
Once a notice has been selected, the register will display the product's information, the date of the notice and the member state(s) of origin and destination.
EMA Press Release
Tags: Distribution, Parallel distribution, re-export