BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.

  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

430 results

Filter

Results per page: 10 20 30

Sorting:

Latest entries first

Relevance

Latest entries first(selected sorting)

Oldest entries first

Selected filter

A.1. Is it possible to apply for an extension? Date: 09. September 2008 Topics: Licensing Type: FAQ

No. The time frame in accordance with Section 31 sub-section 1 number 1 AMG (Arzneimittelgesetz, German Medicines Act) is a statutory period. Therefore, no extension is possible.

C.2. Are e.g. long processing times of the national competent authority or pending appeal procedures and court actions reasons for granting an exemption if the 3-year period is exceeded for such reasons but the medicinal products cannot be marketed due to these pending procedures? Date: 09. September 2008 Topics: Licensing Type: FAQ

No. However, a suspension of the 3-year period can be applied for in such cases (for more information cf. Item A.5.).

C.4. Is an exemption granted if the authorised medicinal product from an MR / DC procedure with Germany as RMS has not/no longer been on the German market for more than three consecutive years, but is required in at least one CMS? Date: 09. September 2008 Topics: Licensing Type: FAQ

Such exemptions can be granted on a case-by-case basis provided the necessary requirements have been fulfilled. Together with the application, the marketing authorisation holder has to prove specifically that the medicinal product is authorised …

A.2. Is it sufficient to make a binding declaration within the 3-year period that the medicinal product will be placed on the market again? Date: 09. September 2008 Topics: Licensing Type: FAQ

No. The law requires that the medicinal product is marketed within the statutory period.

A.4. What happens if submitted applications for exemption pursuant to Section 31 sub-section 1 sentence 2 AMG do not become legally binding within the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG? Date: 09. September 2008 Topics: Licensing Type: FAQ

In the case of pending or not legally effective applications for exemption pursuant to Section 31 sub-section 1 sentence 2 AMG, marketing authorisations do not expire until a legally binding decision has been made. In cases of a legally …

C.3. Can exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG also be granted for "third countries"? Date: 09. September 2008 Topics: Licensing Type: FAQ

Exemptions in accordance with Section 31 sub-section 1 sentence 2 AMG can also be granted for export to a third country for public health reasons. The same criteria as for national public health protection apply to the granting of such …

B.1. When is a medicinal product considered marketed? Date: 09. September 2008 Topics: Licensing Type: FAQ

The term "marketing" is defined in Section 4 sub-section 17 AMG as follows: "Marketing is the keeping in stock for sale or for other forms of supply, the exhibiting and offering for sale and the distribution to others".

It is the BfArM's view that a …

B.3. Does the administration of medicinal products in clinical trials constitute marketing as defined in the AMG? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, medicinal products used in clinical trials can also fulfil the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG.

D.2. Do notifications also have to be made for medicinal products for which marketing authorisation has been applied for but which are not yet licensed in accordance with Section 105 (so-called fictively licensed medicinal products)? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with Section 105 sub-section 1 AMG these medicinal products are considered licensed. Section 105 sub-section 3a AMG defines the exemptions to Section 29 AMG. As these Sections do not include any specifications concerning the …

D.8. Does the obligation to notify the national competent authority in accordance with Section 29 sub-sections 1b, 1c AMG via PharmNet.Bund application "Notifications for Sunset Clause" also apply to products for which either standard marketing authorisation or standard registration procedures are used? Date: 09. September 2008 Topics: Licensing Type: FAQ

No, when employing standard marketing authorisation or standard registration procedures no notifications have to be made via PharmNet.Bund application “Notifications for Sunset Clause”. Informations on the use of products for which either standard …

D.1. Does the obligation to notify the national competent authority also apply to registered medicinal products? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with Section 39 sub-section 2c sentence 2 AMG, Section 31 AMG also applies correspondingly to the expiry of registrations.

F.1. Are notifications in accordance with Section 29 sub-sections 1b, 1c AMG subject to fees? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with the currently valid Fees Ordinance (Besondere Gebührenverordnung BMG (BMGBGebV)) such notifications are subject to fees.

F.2. Are applications for exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG subject to fees? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with the currently valid Fees Ordinance (Besondere Gebührenverordnung BMG (BMGBGebV)) such applications are subject to fees.

B.4. Is the export of medicinal products also considered marketing? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, generally the export of medicinal products can fulfil the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG. A precondition for this is that the batch release of the licensed medicinal product also …

B.2. Does the term 'marketing' include the dispensing of free physicians’ samples supplied by pharmaceutical entrepreneurs? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes. Since samples supplied by pharmaceutical entrepreneurs can be dispensed to physicians on the basis of Section 47 sub-section 4 AMG, they are also considered marketed within the definition of the AMG.

D.7. Is a notification of interruption of marketing also required for suspended marketing authorisations? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, notifications in accordance with Section 29 sub-sections 1b and 1c AMG and with Section 141 sub-section 7 AMG are to be separated procedurally from the provisions of Section 31 sub-section 1 number 1 AMG. This means that the notifications have …

B.5. When does the sunset clause ticker start counting in Germany? Date: 09. September 2008 Topics: Licensing Type: FAQ

As a matter of principle, the end of the shelf-life of the batch last placed on the market by the marketing authorisation holder is counted.

D.3. Are notifications for medicinal products licensed centrally with the EMA also to be submitted? Date: 09. September 2008 Topics: Licensing Type: FAQ

Only licenses within the jurisdiction of the BfArM are subject to the notification procedure. As the EMA is responsible for centralised marketing authorisations, the BfArM does not have to be informed.

D.6. Are notifications required for medicinal products the marketing authorisation of which was renounced by the marketing authorisation holder in accordance with Section 31 sub-section 1 number 2 AMG in conjunction with Section 31 sub-section 4 AMG and which are now still marketed in accordance with Section 31 sub-section 4 AMG? Date: 09. September 2008 Topics: Licensing Type: FAQ

There is no longer a notification obligation for expired marketing authorisations. The prerequisite for such an obligation is an existing license. The renunciation of marketing authorisation in accordance with Section 31 sub-section 1 number 2 …

D.5. Does a renewed notification of marketing have to be made if there was a marketing alliance and the co-marketer is now acting as the pharmaceutical entrepreneur for this product or if a marketing authorisation is transferred? Date: 09. September 2008 Topics: Licensing Type: FAQ

No new notification is necessary if there are no changes in the marketing status. This applies to co-marketing as well as to transfer of licenses.

D.4. Is a (renewed) notification of marketing required for a medicinal product for which post-marketing authorisation was granted after 6 September 2005 and which was marketed previously? Date: 09. September 2008 Topics: Licensing Type: FAQ

No new notification is necessary if the granting of the marketing authorisation does not entail changes of the marketing status. This means that such a notification can be dispensed with if the medicinal product was marketed continuously.

Medicinal Products for Human Use, VOLUME 2B Module 1: Administrative Information application form, May 2008 doc, 387KB, File does not meet accessibility standards Date: 22. May 2008 Topics: Licensing Type: Form

(Formularsatz für den Antrag auf Zulassung eines Arzneimittels beim Bundesinstitut für Arzneimittel und Medizinprodukte und beim Paul-Ehrlich-Institut/Bundesamt für Sera und Impfstoffe (Stand 22.05.2008))

Processing Statistics of the BfArM 2007 PDF, 357KB, File does not meet accessibility standards Date: 26. February 2008 Topics: Licensing Type: Download

State: January 2008

Criteria for Scientific Material in Support of Clinical Indications in Homeopathy PDF, 56KB, File does not meet accessibility standards Date: 12. February 2008 Topics: Licensing Type: Download

Criteria for Scientific Material in Support of Clinical Indications in Homeopathy

European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) - Annex 2 PDF, 52KB, File does not meet accessibility standards Date: 03. July 2007 Topics: Licensing Type: Form

Processing Statistics of the BfArM 2006 PDF, 382KB, File does not meet accessibility standards Date: 20. February 2007 Topics: Licensing Type: Download

State: February 2007

Guide to Submission of Applications for Marketing Authorisations of the Decentralised Procedure (DCP) (according to Art. 28(3) of Directive 2001/83/EC) Date: 19. December 2006 Topics: Licensing Type: Article

In order to speed up the processing of the applications at validation the following current requirements for submission should be taken into account.

3rd Announcement on Clinical Trials of Medicinal Products in Humans PDF, 1,019KB, File does not meet accessibility standards Date: 10. August 2006 Topics: Licensing Type: Announcement

Processing Statistics of the BfArM 2005 (in German only) PDF, 59KB, File does not meet accessibility standards Date: 03. March 2006 Topics: Licensing Type: Download

Stand: Januar 2006

Processing Statistics for the years 1986 through 1994 (in German only) PDF, 11KB, File does not meet accessibility standards Date: 18. May 2005 Topics: Licensing Type: Download