d/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16_annex_en.pdf MDCG 2024 -16 4 7 Description of the Interruption or discontinuation of supply (information requested as per Art 10a) Specify [...] 2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf MDCG 2024 -16 2 4 [...] Specify other: https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16_annex_en.pdf MDCG 2024 -16 5 The medical device is usually marketed and supplied to

Referenced at:

• Medical devices vigilance

General-EMEA/CMDh/619614/2008

Referenced at:

• DCP/MRP/RUP/SRP Slots

17 Well-established use application (Article 10a of Directive No 2001/83/EC) 37 Homöopathika Homeopathic marketing authorisation procedure (Article 16 of Directive No 2001/83/EC) 521 Generic application [...] (Article 10(3) of Directive No 2001/83/EC) 3 Well-established use application (Article 10a of Directive No 2001/83/EC) 16 Fixed combination application (Article 10b of Directive No 2001/83/EC) 275 Full application [...] Reg 10 Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) 22 Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6) 2 Hybrid application (Article 13(3)

Referenced at:

• Statistics on medicinal products

the current template the MAH should make a commitment to submit a variation within 3 months after end of MRP/RUP. If the dossier does not contain a Module 1.8.2 a variation application has to be submitted [...] by providing a manufacturer’s EU declaration of conformity, an EU certificate issued by a Notified Body or a Notified Body opinion? ☐ Yes ☐ Not applicable, as the medicinal product is a Drug-Device C [...] authorisation ☐ Art. 8(3) ☐ Art. 10(1) ☐ Art. 10(3) ☐ Art. 10(4) ☐ Art. 10a ☐ Art. 10b ☐ Art. 10c ☐ Art. 16a Is the product a duplicate? If yes, please state the name and MA/identification number/procedure

Referenced at:

• DCP/MRP/RUP/SRP Slots

registration as a user includes a so-called 'administrator authorization'. In order to obtain this authorization a legitimation of management board, a so-called Letter of Authorization (LoA), is required [...] "You are trying to open a file, 'ASPRegister.xml', whose format is different from the one specified in the file extension. Make sure that the file is not corrupted and comes from a trusted source before [...] not be changed and further use is at your own risk. Use of data interfaces (web services) When using a BASG data interface, the corresponding terms of use are deemed to be accepted; no further explicit consent

Diese Gebührenverordnung findet Anwendung auf alle Anbringen, die ab dem 01.04.2000 bis einschließlich 19.01.2006 beim Bundesministerin für Arbeit, Gesundheit und Soziales eingegangen sind.

Referenced at:

• Fees

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International-Aarhus (DK257551) that a 16p13.11 duplication was detected during prenatal screening of a donor-conceived fetus.

The marketing authorization holder has informed its supplied customers in a letter dated April 16, 2018, that a shortfall in the protein nitrogen content was detected during an internal quality control and that the affected batch of the Prick Test…

The marketing authorization holder informed its supplied customers in a letter dated December 16, 2015, that a reduced active ingredient content was detected in the above batch in the course of routine stability tests, so that the shelf life until…

Änderungen gegenüber der Vorversion

Referenced at:

• Electronic application