TURNING OUR VISION IN TO HEALTH
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.
​
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 Affordable Medicines for Europe (AME) 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 Portugal. 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, Quantung 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 Quantung'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
Please have a look at the video published from the Affordable Medicines Europe association, providing even more details regarding licensed parallel distribution of medicine’s in Europe. (viewtime: approx. 2 minutes)
How does a reimport work?
Reimports are original drugs that are produced in a country such as Portugal by multinational pharmaceuticals companies, who sell them within Europe via their own distributors.
Quantung researches, purchases and imports these original pharmaceuticals from 25 European countries and distributes them at a lower cost either via its partners.
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.
Quantung researches, purchases and imports these original drugs from 25 European countries and distributes them at lower cost as EU pharmaceuticals via its subsidiary in the German and Austrian markets. So Quantung's transports partners these original medicinal products to the respective target markets in parallel to multinational pharmaceuticals companies.
Safety and quality
Are imported EU medicinal products safe?
QUANTUNG Pharma, is an authorized manufacturer of pharmaceuticals and hence subject to the highest quality assurance standards. All EU medicinal products produced by QUANTUNG Pharma and distributed by its subsidiaries 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 to help improve the safety of pharmaceuticals for consumers.
How does QUANTUNG Pharma, guarantee that only original pharmaceuticals are imported?
All EU pharmaceuticals produced by QUANTUNG Pharma and distributed by its subsidiaries 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 QUANTUNG 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?
QUANTUNG 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.
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 Quantung'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
Please have a look at the video published from the Affordable Medicines Europe association, providing even more details regarding licensed parallel distribution of medicine’s in Europe. (viewtime: approx. 2 minutes)
How does a reimport work?
Reimports are original drugs that are produced in a country such as Portugal by multinational pharmaceuticals companies, who sell them within Europe via their own distributors.
Quantung researches, purchases and imports these original pharmaceuticals from 25 European countries and distributes them at a lower cost either via its partners.
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.
Quantung researches, purchases and imports these original drugs from 25 European countries and distributes them at lower cost as EU pharmaceuticals via its subsidiary in the German and Austrian markets. So Quantung's transports partners these original medicinal products to the respective target markets in parallel to multinational pharmaceuticals companies.
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‘ QUANTUNG to the registration owner (EMRAmed) => secure clarification process is in progress.
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.
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 Quantung 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
Please have a look at the video published from the Affordable Medicines Europe association, providing even more details regarding licensed parallel distribution of medicine’s in Europe. (viewtime: approx. 2 minutes)
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.
Quantung Pharma researches, purchases and imports these original drugs from 25 European countries and distributes them at lower cost as EU pharmaceuticals via its subsidiary in the German and Austrian markets. So Quantung's transports partners these original medicinal products to the respective target markets in parallel to multinational pharmaceuticals companies.
How does a reimport work?
Re-imports are original drugs that are produced in a country such as Portugal by multinational pharmaceuticals companies, who sell them within Europe via their own distributors.
Quantung Pharma researches, purchases and imports these original pharmaceuticals from 25 European countries and distributes them at a lower cost either via its partners.