20.11.2022
PARALLEL IMPORTATION & PARALLEL DISTRIBUTION
PARALLEL IMPORTATION
Parallel importation is the importation from an EU Member State or a country within the European Economic Area of a medicinal product, which has a Marketing Authorisation in Slovak republic. The importer may be someone other than the importer appointed by the marketing authorisation holder of the product on the Slovak market. The medicinal product may then be parallel imported in Slovak republic provided that the importer obtains a licence to market the product.
According to §19 in Act no. 362/2011 Coll. Act on Medicines and Medical Devices, medicines must be nationally approved in order to be marketable in Slovak republic.
Exception: medicines centrally approved in the EU.
Basics of the approval procedure
A parallel importer who simply buys a finished medicine that is already sold in another Member State does not have "authorisation documentation" from the original manufacturer in the exporting EU country to demonstrate its quality, efficacy and safety. Therefore, he must submit part of the documents required by law.
Documents will be checked with each application as part of a approval process. For this purpose, the SIDC contacts, among other things, the licensing authority of the relevant EU exporting country and has the information on the imported medicine submitted to the parallel importer's application for approval confirmed. Admission will then only be granted if the law requirements are met. A parallel importer may sell a medicinal product in the Slovak Republic only after approval.
Parallel import licence
The validity of the licence for parallel import of a medicinal product is one year; this licence can be extended for another year. The importer has to apply for extension of the licence at least 3 months before licence expires.
Importation
In accordance with §18 line 1 letter h) point 1 of Act no. 362/2011 Coll. on medicines and medical devices, the wholesale distribution authorisation holder is obliged to submit to the SIDC within seven days after the importation of the medicines a list of the imported medicines, indicating the number and number of the batch or production number, and upon request submit their batch release analytical certificates. This obligation applies also in case of parallel imported medicines.
A medicinal product is placed on the market for the first time
The parallel importer is obliged to notify the MAH or his authorized representative in the Slovak Republic on the start of the parallel import of the medicinal product.
The marketing of a parallel imported medicinal product
In accordance with §18 line 1 letter i) of Act no. 362/2011 Coll. On medicines and medical devices, the wholesale distribution authorisation holder is obliged to submit a report to the state institute within seven days after the end of the quarter on the amount and type of human medicines delivered to the domestic market. This obligation applies also in case of parallel imported medicines.
The marketing of a medicinal product is being discontinued or interrupted (including a possible shortage) or placed on the market again following an interruption.
This obligation does not apply to parallel import marketing authorisations.
Reporting quality defects
Paralel importers have to report any quality defects in medicinal products to the SIDC by email to alert@sukl.sk.
Reporting suspected adverse drug reactions
Parallel importers have to report any suspected adverse drug reactions to the marketing authorisation holder of the reference medicinal product.
Batch Recalls
Parallel importers are required to ensure that there is a clear audit trail from the supplier (i.e., authorised distributor or manufacturer) in the source country. In the case of a recall of a batch of the parallel imported product in the source country, it is imperative that the parallel importer is informed by the supplier so that the parallel importer can take appropriate action. The SIDC requires there to be a contract between the supplier in the exporting Member State and the parallel importer in Slovakia to ensure that information on recalls is passed to the parallel importer; this will be requested in the course of inspections of manufacturers and wholesalers. In addition, there should be a Standard Operating Procedure that covers the respective responsibilities of the supplier and the parallel importer.
Note on trademark law
The State Institute for Drug Control is not responsible for examining and adjudicating trademark law issues. Various statements on trademark issues can be found, for example, in the “Communication from the Commission, Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted” - COM(2003) 839 final - of December 30, 2003.
PARALLEL DISTRIBUTION
Parallel distribution of medicines to the Slovak Republic concerns only centrally authorized medicines.
A public register of parallel distribution is now available on the EMA website which provide up-to-date information on parallel distribution notices currently held by the EMA.
Where a product already includes Slovak republic as a Member State of Destination (MSD), the products can already be placed on the market in Slovakia through the listed parallel distributor/s for that product.
The State Institute for Drug Control should be informed of the intent to place the parallel distributed product on the Slovak market by sending a copy of the notification letter sent to the EMA by the parallel distributor, and sending copies of the labelling/mock-ups to be placed on the Slovak market, by e-mail to subezny.dovoz@sukl.sk prior to marketing.
In accordance with §18 line 1 letter h) point 1 of Act no. 362/2011 Coll. on medicines and medical devices, the wholesale distribution authorisation holder is obliged to submit to the SIDC within seven days after the importation of the medicines a list of the imported medicines, indicating the number and number of the batch or production number, and upon request submit their batch release analytical certificates. This obligation applies also in case of parallel distributed medicines.
In the case of parallel distribution of medicinal products for which a marketing authorisation has been granted via the centralised procedure, quality defects should be reported to both the EMA and the SIDC.
If you have any questions to this topic, please send your e-mail to subezny.dovoz@sukl.sk.
