Questions & answers

We have collected the most frequently asked questions on the import and distribution of EU medicinal products, trade with original pharmaceuticals 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 Verband der Arzneimittel-Importeure Deutschlands e.V. (German association of importers of medicinal products), the European Association of Euro-Pharmaceutical Companies (EAEPC) and IMS Health GmbH & Co. KG (IMS Health).

EU pharmaceuticals
What does the term 'EU pharmaceuticals’ or ‘EU medicinal products' mean?

EU pharmaceuticals or EU medicinal products are original drugs that are produced in an EU country and parallel imported or reimported for example to Germany. An imported original product is and remains an original product.

Which original pharmaceuticals are available to purchase as EU imports?

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.

Why do EU medicinal products have labels?

The information found on pharmaceuticals packaging must be in the corresponding national language. In order to comply with the legal requirements on reimported and parallel imported pharmaceuticals, MPA Pharma produces leaflets, labels and even entirely new packaging containing all of the required information in the relevant national language.

Reimports and parallel imports
How does the business model for reimports and parallel imports work?

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 MPA Pharma'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 click here for more information: Attractively priced originals

How does a reimport work?

Reimports are original drugs that are produced in a country such as Germany by multinational pharmaceuticals companies, who sell them within Europe via their own distributors.

MPA Pharma researches, purchases and imports these original pharmaceuticals from 25 European countries and distributes them at a lower cost either via its subsidiary EMRAmed in the German and Austrian markets or via its subsidiary Paranova in the Scandinavian countries Denmark, Sweden and Finland. 

What is a parallel import?

Parallel imports are original drugs that are produced by multinational pharmaceuticals companies within Europe and sold in countries such as Germany via internal distribution channels. Parallel imports make up some 90 percent of all imports.

MPA Pharma researches, purchases and imports these original drugs from 25 European countries and distributes them at lower cost as EU pharmaceuticals via its subsidiary EMRAmed in the German and Austrian markets, and via its subsidiary Paranova in the Scandinavian countries Denmark, Sweden and Finland. So MPA Pharma transports these original medicinal products to the respective target markets in parallel to multinational pharmaceuticals companies. 

How are EU pharmaceuticals imported to Germany?

Please click on the link to find out more about the journey of EU medicinal products: Where do EU pharmaceuticals come from?

Safety and quality
Are imported EU medicinal products safe?

MPA Pharma is an authorized manufacturer of pharmaceuticals and hence subject to the highest quality assurance standards. All EU medicinal products produced by MPA Pharma and distributed by its subsidiaries EMRAmed and Paranova 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.

We also support the EU's securPharm project via our distribution subsidiary EMRAmed to help improve the safety of pharmaceuticals for consumers. 

How does MPA Pharma guarantee that only original pharmaceuticals are imported?

All EU pharmaceuticals produced by MPA Pharma and distributed by its subsidiaries EMRAmed and Paranova comply with the relevant national drug law  or the requirements of the European Medicines Agency. The distribution of nationally licensed EU medicinal products in the form of parallel imports requires the approval of the national competent authorities . For centrally authorised EU medicinal products, a notice of a completed notification procedure must be granted by the European Medicines Agency.

Are EU medicinal products produced safely?

At MPA Pharma, 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.

How safe is the transportation of EU pharmaceuticals?

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.

How safe is the storage of EU pharmaceuticals?

MPA Pharma guarantees that pharmaceuticals are stored professionally in our own cold storage and that all steps of the professional 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: Safety and Quality

 

Falsified Medicines Directive and securPharm
What exactly is the Falsified Medicines Directive (Directive 2011/62/EC) or securPharm?

securPharm is an initiative to protect the pharmaceutical market in Germany from counterfeit medicines entering into the legal supply chain. The focus is on patient protection.

The goal of the legislation: Package-level counterfeiting protection related to prescription-based human medicines through the establishment of a European security network for the legal supply chain.
securPharm is the German building block in this network. Counterfeit protection applies to medicines for which the EU Commission and the national authorities assume a risk of counterfeiting.

Legal basis:

  • Falsified Medicines Directive 2011/62/EC
  • Commission Delegated Regulation (EU) No 2016/161
When will the Falsified Medicines Directive (Directive 2011/62/EC) come into force?

Starting with 9 February 2019, each prescription-based medicine must be produced with two security features according to the European Directive.
Such medicines must be authenticated by pharmacies prior handover to the patient.

Rx-medicines that have been produced and released for the market until 8 February 2019 may still be issued without a 2D code and seal.

Which medicines are not covered by the EU Directive?

Only pharmacy-only products are not verifiable (e.g., medical devices and most OTC articles, etc.).

What are the security features?

The so-called 'security features' are complementary measures to the already existing regulations and rules used in the legal supply chain:

  • - 2D code with plain text (Unique Identifier): product code, batch, expiry date & serial number
  • - Tamper-evident closure: e.g. seals

Transnational legislation is considered important in the fight against organised crime. On short: securPharm stands in the context of several measures as an additional security method used to protect patients against counterfeit medicines. Individual recognition features and tamper-evident closure are examples for this.

How do the security features work?

The Falsified Medicines Directive (FMD) makes counterfeiting easier to recognise and thus less attractive, since the handover of a medicine to patients is only carried out after a positive authentication. Counterfeit medicine with an identical serialisation number will be detected in the legal supply chain from the first pack, because each Unique Identifier can be used only once. The smuggling of stolen goods in the legal supply chain should be prevented by being able to block serialisation numbers.

Who does what throughout the process?

Each trade level takes important security steps

Manufacturers create individual serialisation numbers in the production process and load them into a database system in conjunction with the package.

Wholesalers will verify the content of the 2D codes on all package returns from pharmacies and other wholesalers, as well as any medicine that is not supplied by the manufacturer or its wholesaler.

Reimporters and parallel traders must inspect the security features (seals and the content of the 2D codes) when importing prescription medicines, and then must book the latter before repackaging from the systems of the respective EU HUB. New security features (seal and a 2D code) are generated. The contents of the 2D code will be registered at the EU HUB.

Pharmacies then check the security features: the content of the 2D code (verification) and the integrity of the seals (tamper-evident closure) are checked. The handover of medicines takes place only after a successful positive verification. With the handover of the medicine to the patient, the pharmacist logs off the packaging from the German HUB.

What is MPA Pharma doing to implement the Falsified Medicines Directive?

Overall, importers are treated just like original manufacturers and significant changes in our processes are necessary to meet the requirements. In order to make all 2D codes available with plain text, all involved departments must enter all relevant master data on the system side and upload them to the German HUB via EU HUB. It's not just about modification of processes, it's also about real investment in new machines and jobs.

  • Goods Receipt: We scan, read and verify each packaging.
  • Production: We read & verify each packaging; log off goods via EU HUB from the respective national HUB & repackage; issue new 2D codes, including a uniquely serialisation number for the selling country & upload information via EU HUB electronically to the relevant national HUB.
  • Goods warehouse: We take care of returns: Goods are destroyed, reworked or returned to the shipping warehouse.

For suspected counterfeit products (alert): Feedback to ‚onboarding partner‘ (MPA Pharma) to the registration owner (EMRAmed) => secure clarification process is in progress.

What investment has MPA Pharma made to implement the EU Directive?

MPA Pharma investments amount to around EUR 2 million in hardware and software.

What is changed for pharmacies?

Pharmacies check the security features: the content of the 2D code and the integrity of the seals (tamper-evident closure) are checked. The handover of medicines takes place only after a successful positive verification.

Who can pharmacies contact if they have any questions?

Customers are welcome to contact the service team of our distribution company 'EMRAmed Arzneimittel' if they have any questions: Kundenservice-Apotheke@EMRAmed.de or by telephone: 0800/ 3672 634.

Cost savings
How much can reimports and parallel imports save in costs?

In Germany the sale of EU pharmaceuticals result in direct cost savings of around 240 million euros per year with the potential to lift this figure to more than 340 million per year. The German health care system also benefits from the dampening effect of competitive imports on prices, which is worth some 3 billion euros. (Source: 2014 study by VAD/Prognos on the import of pharmaceuticals, 'Import von Arzneimitteln').

According to data published by IMS Health, in 2013 some 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').

What is so attractive about reimports and parallel imports?

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.

What are the benefits for pharmacies?

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. 

What are the benefits for patients?

Patients benefit from EU pharmaceuticals with the exact same active ingredients and produced in the same high quality but which often cost less than originals, thus reducing patient co-payments. Imports help to stabilise health insurance contributions by relieving the pressure on the entire health care system. 

What are the benefits for public health insurance funds and private insurers?

Low-cost EU pharmaceuticals alleviate the cost pressure on the health care system whilst increasing the dampening effect of competitive imports on prices. Imported pharmaceuticals also help to promote the conclusion of discount agreements with manufacturers of original drugs, which generates additional cost savings for the health care system. Thus EU medicinal products substantially stabilize  health insurance contributions.

What are the benefits for pharmaceutical wholesalers?

The import of EU pharmaceuticals is a key basis for making prices attractive throughout the entire value chain: from wholesalers, through pharmacies to patients.

What are the benefits for Germany as a place to do business?

The import industry is largely made up of small and medium-sized enterprises that form the economic backbone of their respective countries. For example, in Germany some 3,000 individuals are employed across 57 import businesses. Around 540 of these employees work for the MPA Pharma group, whose taxes and contributions help to strengthen Germany as business location.

Business areas
What are MPA Pharma's hallmarks as a leading producer of high-quality EU pharmaceuticals?

MPA Pharma has 35 years of excellence and experience as a pharmaceuticals manufacturer of EU medicinal products and is characterised 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. 

As a patient, where and how can I purchase products from MPA Pharma?

Patients in Germany, Denmark, Sweden, Finland and Norway can buy or order EU pharmaceuticals produced by MPA Pharma and distributed by its subsidiary companies EMRAmed and Paranova in retail pharmacies. Patients in Austria can obtain prescription EU pharmaceuticals distributed by EMRAmed from retail pharmacies or dispensing doctors.

I am a pharmaceutical wholesaler. How can I obtain pharmaceuticals from MPA Pharma?

Please get in touch with our experts.

I am a producer of original pharmaceuticals or a pharmaceutical wholesaler. How do I sell products to MPA Pharma?

Please get in touch with our experts.

What contract manufacturing services does MPA Pharma offer?

MPA Pharma offers high quality packaging  or repackaging of pharmaceuticals and medical devices.

MPA Pharma also offers the production of specified folding cartons for pharmaceuticals and medical devices as well as the print of individual labels and leaflets. 

Legal Framework
What legal framework is in place for reimports and parallel imports?

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  

All EU pharmaceuticals produced by MPA Pharma and distributed by its subsidiaries EMRAmed and Paranova 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 medicinal products 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 for the EU pharmaceuticals in the corresponding national language are designed and used. 

At MPA Pharma, every single step in the production process conforms both to good manufacturing practices (GMP) and 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.

The distribution of nationally licensed EU medicinal products in the form of parallel imports requires the approval of the national competent authorities. For centrally authorised EU pharmaceuticals, a notice of a completed notification procedure must be granted by the European Medicines Agency.

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.