Questions & answers
We have collected the most frequently asked questions on import and distribution of EU medicinal products and our business model. Please click on the question to see the answer.
The facts and figures are sourced from company information as well as from data provided by the European Association of Euro-Pharmaceutical Companies (EAEPC) and IMS Health GmbH & Co. KG (IMS Health).
EU pharmaceuticals or EU medicinal products are original drugs that are produced in an EU country and parallel imported to, for example, Scandinavian countries. An imported original product is and remains an original product.
Our distribution subsidiaries offer you an extensive range of patented, non-patented and generic products, as well as over-the-counter EU pharmaceuticals, narcotic drugs, and medical devices.
The information found on pharmaceutical packaging must be in the corresponding national language. In order to comply with the legal requirements on parallel imported pharmaceuticals, Paranova produces leaflets, labels, and even entirely new packaging containing all the required information in the relevant national language.
The prices for identical original medicinal products can vary across Europe due to the different health care systems in place. These price variations form the basis of Paranova's business model: We identify branded pharmaceuticals that are manufactured in Europe and which we can offer at a lower price in our target markets. We import these pharmaceuticals, repackage them with specialized packaging and leaflets in the corresponding national language, and release them for distribution. This helps us to bring down the costs of health care significantly.
Please have a look at the video published by Affordable Medicines Europe, providing even more details regarding licensed parallel distribution of medicines in Europe (view time: approx. 2 min).
Parallel imports are original drugs that are produced by multinational pharmaceutical companies within Europe and sold in, for instance, Scandinavian countries via internal distribution channels. Paranova researches, purchases, and imports these original drugs from European countries and distributes them at a lower cost as EU pharmaceuticals in the Scandinavian countries Denmark, Norway, Sweden, and Finland as well as the German and Austrian markets. Paranova transports these original medicinal products to the respective target markets in parallel to multinational pharmaceuticals companies.
Our parent company, MPA Pharma GmbH is an authorized manufacturer of pharmaceuticals and hence subject to the highest quality assurance standards. All EU medicinal products produced for Paranova by MPA Pharma GmbH comply with the relevant national drug law or the requirements of the European Medicines Agency.
We monitor and document all steps of the process, from researching new EU pharmaceuticals right through to the delivery of every single pharmaceutical product in pristine condition. Our experts work hand in hand with one another to make sure that all products are repackaged and stored correctly, and that only high-quality packaging materials in the corresponding national language are designed and used.
The distribution of nationally licensed EU medicinal products in the form of parallel imports requires the approval of the national competent authorities. For centrally authorized EU medicinal products, a notice of a completed notification procedure must be granted by the European Medicines Agency.
For Paranova products, every single step in the production process conforms both to good manufacturing practices (GMP) and the legal requirements of the applicable national regulations. Our GMP-compliant quality management system is an important tool that enables us to safeguard the required quality of our products. We monitor and document all steps of the process, from researching new EU pharmaceuticals right through to the delivery of every single pharmaceutical product in pristine condition.
Our medicinal products are delivered in line with good distribution practices (GDP) and legal requirements of the applicable national regulations. Our specialized logistic partners ensure strict temperature control is maintained for our pharmaceuticals right through to delivery. The vehicles constantly monitor the exact temperature throughout transportation.
Paranova guarantees that pharmaceuticals are stored professionally in cold storage and that all steps of the handling process are documented without exception. This procedure is in line with good distribution practices (GDP) and legal requirements of the applicable national regulations. Customers have the opportunity to visit our production facilities to see for themselves the rigorous standards in place throughout all of our processes. Please click here for more information on safety and quality.
Over the past years, falsification of medicines has become a growing concern on the European market. Along with our parent company, MPA Pharma GmbH, we are deeply committed to ensuring patient safety and support all initiatives to prevent falsified medicines on the European market.
Paranova adheres to the legal framework established by the European Council/European Parliament. All prescription products are subject to these directives:
- Falsified Medicines Directive (Directive 2011/62/EU).
- Commission Delegated Regulation (EU) 2016/161.
The directives ensure control and harmonization on use of a unique identifier and an anti-tampering device, which both have the purpose of preventing falsified medicines within the European Union.
A unique identifier is a unique code placed on each pharmaceutical product, in the form of a matrix barcode or Quick Response (QR) code. The code contains information about the product and a unique numbering sequence, which is uploaded to a European database. The European database controls the status of each pack. When pharmacies hand out the product to the patient, the code is verified and the status is changed in the database. This ensures that only correctly manufactured products are handed out to the patients and prevents falsified products from making their way into the legal distribution channels.
An anti-tampering device is a physical protection, implemented on the medicinal products, that prevents unwanted changes to the products. At Paranova, we use transparent sealing labels, with a special type of glue, on all our prescription products. The sealing labels are placed on each open end of the product. If the product is opened/breached, it will be clearly visible by either the sealing label being cut or the box itself being torn.
Along with our parent company, MPA Pharma GmbH, Paranova scans and verifies the status of each prescription product we import using the unique identifier on the products. The unique identifier and the status of each product are controlled and logged in a European database, which only authorized manufacturers can upload data into.
If a prescription product cannot be verified, it will not be allowed to move any further in our repacking/production process. As such, falsified products cannot enter into our supply chain.
In addition to this, Paranova only imports products from nationally authorized manufacturers and wholesalers throughout the European Union.
We are happy to help you with any concerns you may have. Please find the appropriate contact information here.
A study shows that the total direct savings on medicine for the period 2004 to 2009 in Denmark, Sweden, Germany, and the United Kingdom amounted to €2.5 billion, corresponding to an average annual direct saving from parallel imports for the period of €418 million. Adding to this is the indirect savings, where price elasticities is a significant contributor. (Source: 2011 study by Enemark & Pedersen, ‘Parallel imports of pharmaceuticals in Denmark, Germany, Sweden and the UK, 2004-2009’)
According to data published by IMS Health in 2013, approximately 5 percent – worth around 5.2 billion euros’ – of prescription drugs in Europe took the form of imports. In 2011, imported EU medicinal products generated direct cost savings for the UK, Denmark, and the Netherlands of around 150 million euros. The share of direct savings resulting from parallel imports in France virtually doubled between 2010 and 2011, and in 2012, Sweden reported that 20 percent of its prescription drugs were imported EU pharmaceuticals. (Source: 2013 study by EAEPC/Pedersen, 'The Parallel Distribution Industry – a closer look at savings').
The prices for identical original products vary across Europe due to the different health care systems in place. Imported pharmaceuticals cost substantially less than original products, which benefits everyone involved.
Our distribution subsidiaries offer pharmacies indirect cost savings through the purchasing of lower cost imports: either through the purchasing from our pharmaceutical wholesalers or through attractive purchasing conditions when ordering directly.
Patients benefit from import of EU pharmaceuticals as the products are identical to the already marketed ones but often cost less, thus, reducing patient co-payments. Imports help to stabilize health insurance contributions by relieving the pressure on the entire health care system.
Low-cost EU pharmaceuticals alleviate the cost pressure on the health care system whilst increasing the dampening effect of competitive imports on prices. Thus, EU medicinal products substantially stabilize health insurance contributions.
The import of EU pharmaceuticals is a key basis for making prices attractive throughout the entire value chain: from wholesalers, through pharmacies to patients.
Paranova has more than 30 years of excellence and experience as a pharmaceuticals distributor of EU medicinal products and is characterized by its tradition as a family-run business with flat hierarchies and efficient decision-making channels. A strong partnership ethic in our dealings with customers along with an extensive and attractive product range offered on fair terms form the basis of our long-lasting, successful business relationships. Our activities are guided by our philosophy of delivering quality in every respect, and our long-standing employees put this into practice every single day.
Patients in Denmark, Sweden, Finland, and Norway can buy or order EU pharmaceuticals distributed by Paranova in retail/online pharmacies. Sales to hospitals will go through the Danish buying organization Amgros.
The legal basis for importing EU pharmaceuticals is founded on two key principles established by the European Union:
- The free movement of goods among member states
- The exhaustion of patent rights and trademarks
European Falsified Medicines Directive (Directive 2011/62/EC): Since February 9, 2019, each prescription-based medicine repacked for Paranova receives a 2D code with plain text, including a uniquely serialization number and a tamper-evident closure, guaranteeing the integrity of the packaging by means of seals. Please click on the section ‘Safety and prevention of falsified medicines’ for more information.