Suchen Sie hier direkt nach Handelsname oder Wirkstoff des benötigten Einzelimports gem. § 73 Abs. 3 AMG:
Named Patient Imports
Health is at the centre of our work and each individual case is crucial.
We therefore process all enquiries or orders with our full dedication, expertise and experience:
For more than 20 years, we have been making the world's innovations available in Germany before they are authorised, or we have been closing supply gaps in the event of supply bottlenecks or in the case of medicinal products that are not (or no longer) authorised nationally - within the framework of Named Patient Imports in accordance with Section 73 (3) of the German Medicinal Products Act (AMG).
That's why PHARMORE is the right partner for your Named Patient Imports
PHARMORE is a medium-sized German family-run business based in Ibbenbueren, Germany.
High quality standards are a matter of course for us and out of conviction,
we work strictly according to GDP guidelines.
With us you get PHARMORE:
Fast
If we receive your order by 4 p.m. on weekdays, we usually deliver products we have in stock within the next working day.
Customs warehouse
As one of the leading suppliers of Named Patient Imports, we keep many of the permanently needed Named Patient Imports on stock in our customs warehouse.
Reliable
We stand for reliability, quality and transparency. We are also your specialist with regard to questions on the applicable legal regulations.
Global
Products we do not have in stock, we will get them for you – from all over the world. Thanks to our network, we make global products available to you. We look forward to receiving your enquiry!
Experienced
Benefit from more than 20 years of experience as one of the leading providers of professional Named Patient Imports in accordance with Section 73 (3) AMG – quality always shows!
Expect (PHAR)MORE
We offer pharmaceutical-scientific information and research from our corresponding specialist department.
Quick search in our Named Patient Import database
Find the medicine you need here in our Named Patient Import database,
which is updated daily, and request it directly from us:
Go to the quick search
Named Patient Import according to Section 73 (3) AMG: in which cases?
This link will take you to the current version of the Medicinal Products Act on the site of the Federal Ministry of Justice.
Innovations
Novel, innovative and therapeutically significant drug therapies
(e. g. from the USA) can be procured from abroad for certain individual cases even before they are authorised in Germany.
Supply bottlenecks
Temporary supply gaps caused by supply bottlenecks can be closed.
Cessation of distribution
Long-established medicinal products that are not or are no longer distributed nationally, particularly for economic reasons, can be procured under certain conditions.
What needs to be considered?
The following applies in principle to the order of a Named Patient Import according to Section 73 (3) AMG:
- Ordering is only possible through pharmacies.
- By order of a single person.*
- In small quantities.*
- Dispensing within the scope of the existing pharmacy operating licence.
*Exception see "Import facilitation for hospital pharmacies"
Additionally the following applies to the medicine (to be procured) itself:
Marketability in the state of origin:
The medicinal product may be legally placed on the market in the state from which it is imported into Germany.
Supply gap:
There are no medicinal products available in Germany for the therapeutic indication in question, which are identical in terms of the active substance and comparable in terms of the strength.
IMPORTANT:
The import and distribution of medicinal products for doping purposes (Section 2 Anti-Doping Law), as well as of unsafe medicinal products (Section 5 AMG) and expired medicinal products (Section 8 AMG) is prohibited – without restriction even in the case of Named Patient Imports.
Prescription-only medicinal products
For medicinal products procured within the scope of Named Patient Imports according to Section 73 (3) AMG,
(1) the prescription requirement according to Section 48 AMG applies, if procured from countries within the EU/EEA. If the imported medicine contains active substances that are subject to prescription, then the supply is subject to a physician's prescription.
(2) a prescription is always required, when sourced from countries outside the EU/EEA.
This even applies to medicinal products that are available without prescription in the country of origin.
Documentation of Named Patient Imports:
The following information must be recorded for Named Patient Imports in accordance with Section 18 of the Ordinance on the Operation of Pharmacies:
- the name of the imported medicine,
- the name or company name and address of pharmaceutical entrepreneur,
- the batch number, quantity and dosage form of the medicine,
- the name or company name and address of the supplier,
- the name and address of the person who shall receive the medicine,
- the name and address of the prescribing physician or the prescribing veterinarian,
- the date of order placement and dispensation,
- the initials of the pharmacist who dispensed the medicine or supervised the dispensation.
If special instructions are required for reasons of medicinal safety, these must be communicated at the time of dispensing.
These records must be kept complete for at least one year after the expiry date, but not less than five years.
SPECIAL: import facilitation for hospital pharmacies
Especially for hospital pharmacies and pharmacies supplying hospitals, the legislator has provided import facilitation under the condition of marketability in the state of origin and an existing supply gap.
This means that, in the event of supply bottlenecks, there is the option of temporarily stocking up on Named Patient Imports
- to an appropiate quantity,
- to ensure proper treatment of the hospital's patients.
Liability
In principle, liability for authorised medicinal products in Germany is regulated in Section 84 (1) AMG as "absolute liability" and in Section 94 (1) AMG as "coverage provision".
In the case of Named Patient Imports, however, the absolute liability of the pharmaceutical entrepreneur according to Section 84 AMG does not apply, but rather the Product Liability Act.
"Not all imports are the same" – But what are the differences?
Parallel import
Pharmaceutical manufacturers generally market their products in many countries. Medicines are referred to as parallel-imported drugs if, for example, a third company acquires them in another EU member state and imports them into Germany in order to market them there as well - in parallel with the original pharmaceutical entrepreneur. Parallel-imported medicines have a marketing authorisation in Germany.
Re-import
Similar is the case of re-imports, but with the difference that these drugs were previously manufactured in Germany and exported to other countries. Re-imported finished drugs are also drugs that have authorisation in Germany.
Named Patient Import according to Section 73 (3) AMG
Through a Named Patient Import according to Section 73 (3) AMG, medicinal products which are not (yet) or no longer available in Germany can be procured under certain conditions. This concerns the import of medicines that are not authorised in Germany and their further distribution.