Frequently asked questions
The European Commission has published a communication explaining how the principle of the free movement of goods in the EU is being applied in practice to the parallel distribution of medicinal products.
Parallel distribution is a delivery of a product from an EU / European Union Member State or from an EEA (European Economic Area) Member State that is already approved for the Bulgarian market but by an importer other than the official distributor for the country. Such imports are allowed if the product is identical to the one already authorized for sale in the Member State of destination. In order to help businesses and national administrations make full use of the internal market for medicinal products, the Commission Communication covers the rights and obligations of the stakeholders and the guarantees to which they are entitled under EU law.
Parallel trade is generally based on the principle of the free movement of goods and contributes to the development of the internal market so that more products at different prices are delivered from one national market to another.
Parallel trade with medicinal products creates a real competitive environment and helps regulate the prices of medicinal products in the Member States and should therefore be protected, tolerated and encouraged.
Parallel distributors buy products at lower cost from pharmaceutical manufacturers in one country and sell them to another country where the price is higher. Such trading is legal under the rule of regional exhaustion of the trademark owner’s right applied in the EU and EEA.
Up to date, parallel distributed Rx products have shown a price effect in favor of consumers of 20 to 50% reduction in prescription drug prices.
Parallel distributors are subject to the same regulatory requirements as producers of original or generic products and are under regular control by national and European regulatory authorities.
Article 35 of the Treaty on the Functioning of the European Union (TFEU) states that quantitative restrictions on exports between Member States and all measures having equivalent effect are prohibited. The Court of Justice of the European Union interprets “measures having equivalent effect” as all those introduced by a Member State that directly or indirectly hinder, in fact or potentially, trade within the EU. Art. 36 of the TFEU introduces an exception to the prohibition of Art. 35, but only when it comes to protecting the health and life of people with clear and precise argumentation.
There is no evidence that parallel trade leads to a deficit in the exporting country. Manufacturers and wholesalers are obliged, under EU law, to ensure the continuity of supply of medicinal products at any time. Wholesalers also have “public service obligations” under national law and their business codes, under which they are obliged to ensure sufficient availability for timely delivery of medicines to local pharmacies before undertaking export sales steps.
Drugs marketed by parallel traders are products of original manufacturers, often produced at the same plant for the medicines of local origin. The products for parallel trade are either absolutely identical or contain very small differences in color and excipients. Differences that regulators check for lack of therapeutic consequences. If a manufacturer / a marketing authorization holder criticizes a parallel marketed product, he actually criticizes his own product. The proliferation of each of these drugs is authorized by the national drug agency decision. All products supplied by parallel traders are subject to exactly the same safety provisions as products already positioned on the market. Therefore, there is no additional risk of using drugs imported by parallel distributors. The word “parallel” means only that the supply / sale and marketing of a medicinal product is done outside the distribution network of the manufacturer and his licensees (authorized representatives).
Medicines imported into Bulgaria undergo a repackaging process to adapt the accompanying information to patients in the local language. In the case of repackaging, the secondary packaging (box) and the package leaflet of the imported medicinal product shall be replaced by such in Bulgarian approved BDA. In addition to changing the secondary packaging and the package leaflet, a sticker is placed on the primary packaging (blister, sachet, bottle, etc.) in accordance with the national requirements envisaged in the national legislation. The contents of each packaging material shall be approved by the BDA.
The repackaging process is carried out by companies licensed to produce medicinal products issued by BDA and adhering to Good Manufacturing Practice (GMP).
The sticker on the primary pack (blister, bottle, vial, ampoule, syringe or sachet) means an additional guarantee of origin, quality and safety of the medicine.
Drugs and medical devices from parallel import have an additional guarantee of origin, quality and safety of the medicinal product
- Parallel import drugs are original, high quality and safe, at a lower price, imported from countries of the European Economic Area.
- Each parallel imported medicine is of guaranteed origin proven and verified not only by one but by two executive drug agencies – one in the country from which it is purchased and by BDA in Bulgaria which is issuing permission for this medicine after very strict verification procedure.
- The presence of a sticker shows that very strict internal control of the supply chain has been applied, according to the requirements of Good Distribution Practice (GDP)
- The sticker is a sign that the medicine is from a batch that is certified for Bulgaria by a GMP-licensed manufacturing company (GMP)
- The label on the primary packaging of the product is a mandatory attribute according to the regulations in Bulgaria. It not only does not break the primary packaging but also prevents the medicine from mechanical damage to the integrity of the packaging
Parallel distribution provides an opportunity for Bulgarian patients to buy the same original medicines at lower prices and to have access to a variety of medicines from all EEA countries, not just those registered on the local market.
A large number of medicinal products in Bulgaria are de-registered by the first importer for non-pharmacological safety reasons. The same medicines continue to be sought by patients who, in turn, are forced to use unregulated intermediaries or their relatives to supply products from other EU Member States. Here, as a legitimate alternative, parallel import can be used.
To expand this access, there is a need of refining and amending the current legislation to make our work even more useful to patients and public funds, including to address situations of lack or shortage of medicinal products.
The first online drug-shortage warning platform was presented to patients at the 7th Federation of Bulgarian Patient Forum. It is established by the Bulgarian Association for Medicines Parallel Development (BAMPTD) and is now available 24 hours a day and addresses the signals and questions of our patients and partners.
Through website of BAMPTD in which we are a co-founder and member, we and the other members of the association maintain a hotline for submitting alerts for missing medicines across the country.
This is how we get timely information and, together with other stakeholders and partners, we manage to solve patients’ problems, and which is extremely important – to be able to provide timely assistance.
Our reporting format is extremely convenient and does not require you to fill in your personal data but just a phone for feedback. Please fill in correctly the name of the medicine and the place where you can not find it.