Many entities engaged in business activities related to the handling of medicines or medical devices (particularly suppliers or wholesalers of medicines and medical devices) encounter the terms “parallel import” and “parallel distribution” or “concurrent import” in their commercial relationships — particularly if they conduct their business not only within the Slovak Republic but also within individual member states of the European Union (EU). The purpose of this article is to briefly explain these terms and their meaning, outline the fundamental differences between them, and provide information on the relevant legislation governing them.
Parallel or, alternatively, concurrent trade in medicines is based on the principle of the free movement of goods within the EU internal market. A direct consequence of the principle of free movement is the Cassis de Dijon doctrine, which stipulates that a product lawfully placed on the market in one Member State must be allowed to circulate freely throughout the EU.
Parallel distribution means that centrally authorized medicines placed on the market in one member state of the European Economic Area may be placed on the market by a distributor in any other member state, independently of the marketing authorization holder. Parallel distributors must submit a notification of parallel distribution to the European Medicines Agency (EMA). A parallel distributor does not receive a separate marketing authorization, but instead receives a confirmation from the EMA stating that parallel distribution of the product is permitted, along with information on which types of medicines the authorization applies to.
Parallel importation, on the other hand, applies only to nationally registered medicines and is subject to approval by the competent national authority of the Member State. This refers to imports that are not carried out by the marketing authorization holder or in cooperation with them.
The fundamental difference between parallel import and parallel distribution thus lies in the fact that distribution may only take place after notification to the EMA, whereas import is subject to authorization by a national authority, in our case the State Institute for Drug Control (ŠÚKL).
Pursuant to REGULATION (EC) No. 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 May 2004, laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, notifications regarding the parallel distribution of centrally authorized medicinal products are mandatory throughout the EU. Centrally authorized medicinal products are marketed under the same name in all Member States and must have a marketing authorization. Pursuant to Article 57(1)(o) of this Regulation, it is the EMA’s responsibility to verify that distributed products comply with the conditions set forth in European legislation on medicinal products and with the conditions specified in the marketing authorization. If a medicinal product is distributed in parallel without notifying the EMA or despite its objection, the competent national authorities may take regulatory measures against the parallel distributor.
Slovak legislation recognizes and uses the term “parallel import.” Pursuant to Section 19(1) of Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amendments to Certain Acts, parallel import of a medicinal product means the import of a medicinal product that is registered in the Slovak Republic and also in another Member State, into the Slovak Republic by a person other than the marketing authorization holder in the Slovak Republic or in cooperation with that holder. Parallel importation may be authorized only to a holder of a wholesale distribution authorization for medicinal products.
Parallel importation may be authorized if the parallel-imported medicinal product is registered in another Member State under the same conditions as the medicinal product registered in the Slovak Republic (the so-called “reference imported medicinal product”) and is distributed from that Member State to the Slovak Republic:
· under the same name,
· with qualitatively and quantitatively identical active ingredient(s),
· in the same dosage form and with a similar appearance,
· in the same package size,
· in the same inner packaging and outer packaging with identical graphic design on both packages,
· by the same manufacturer of the medicinal product, except for the manufacturer of the inner packaging, outer packaging, and the package insert.
A parallel-imported medicinal product must not differ from the reference imported medicinal product in terms of quality, efficacy, and safety, and it is used under the conditions specified in the marketing authorization decision for the reference imported medicinal product.
The State Institute for Drug Control (ŠÚKL) decides on the granting of a parallel import authorization for a medicinal product based on an application by the holder of a wholesale distribution authorization for medicinal products for the issuance of a parallel import authorization, which contains the legally required details and attachments. The validity of the authorization for the parallel import of a medicinal product is one year from the date the authorization decision becomes final; this authorization may be extended for an additional year, even repeatedly, upon submission of an application at least three months prior to the expiration of the authorization. The holder of a parallel import authorization for a medicinal product is responsible for the activities they undertake, without prejudice to the liability of the marketing authorization holder for the reference imported medicinal product as established by this Act.
The holder of a parallel import authorization for a medicinal product is subsequently required to:
a) maintain records of the origin, number of packages, and batch numbers of the parallel-imported medicinal product for five years,
b) ensure the suspension of the dispensing or placing on the market of the parallel-imported medicinal product to the same extent as for the reference imported medicinal product in the Slovak Republic or in another Member State from which it is imported, if the suspension of dispensing or placing on the market occurred as a result of non-compliance with the required quality, efficacy, or safety of the medicinal product, or if the marketing authorization has been revoked or has expired in the Slovak Republic or in another Member State from which it is imported,
c) take into account changes in the marketing authorization of the reference imported medicinal product that may affect the quality, efficacy, and safety of the parallel-imported medicinal product,
d) ensure that the packaging, labeling, and other permitted modifications of the parallel-imported medicinal product are carried out only by holders of a manufacturing authorization,
e) label the outer packaging with the words “PARALLEL-IMPORTED MEDICINE” and the identification details of the holder of the parallel import authorization and the manufacturers in such a way that it does not partially obscure the trademark,
f) notify the holder of the marketing authorization for the reference imported medicinal product or their authorized representative in the Slovak Republic of the commencement of parallel importation of the medicinal product and, upon request by the holder of the marketing authorization for the reference imported medicinal product or their authorized representative in the Slovak Republic, provide them with a sample of the parallel-imported medicinal product in the packaging in which it will be placed on the market in the Slovak Republic,
g) ensure the monitoring of medicinal products, in particular by collecting data on adverse reactions, and report recorded adverse reactions to the marketing authorization holder of the reference imported medicinal product and to the authority that issued the authorization for parallel import.
The State Institute for Drug Control (ŠÚKL) shall suspend the authorization for parallel import of a medicinal product
if:
a) the registration of the reference imported medicinal product has been suspended in the Slovak Republic or in another Member State,
b) the holder of the authorization for parallel import of a medicinal product so requests,
and shall revoke it if the holder of the authorization for parallel import of a medicinal product:
a) fails to comply with the conditions specified in the authorization,
b) seriously violates the obligations established by this Act,
c) at the request of the holder of the authorization for parallel import of a medicinal product.
To carry out activities falling under the concepts of parallel import and parallel distribution within the meaning of relevant European legislation and parallel import within the meaning of relevant Slovak legislation, it is necessary to familiarize oneself with the individual legal concepts arising from these legal regulations, as well as with the procedures and interpretations of authorities (including state bodies) in this area.
The law firm Hronček & Partners, s. r. o. has extensive experience in representing companies in the medical and pharmaceutical sectors. If you are facing any issue related to medicines, pharmaceuticals, medical devices, or other products and need assistance, our experts are ready to lend a helping hand.
