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

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

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 [...] defined in § 6a (1) GESG. To perform these sovereign tasks of BASG, AGES is entitled to process personal data for the purpose of registration for eServices for BASG in accordance with § 6a (5) in conjunction [...] "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

Änderungen gegenüber der Vorversion

Referenced at:

• Electronic application

Für Humanarzneispezialitäten: • eAF für Neuanträge gemäß §§ 7a, 9a, 9b, 9c, 9d, 10 Abs. 1(1), 10 Abs. 1 (2), 10 Abs. 9, 10a, 10b, 11, 11a und 12 AMG • eAF für Renewalanträge gemäß § 20 AMG • eAF für [...] tt 1.4, 1.6 § 9d - MAA-Human form mit Zusatzbla tt 1.4, 1.6 § 10, Absatz 1, Ziffer 1 10(1) MAA-Human form § 10, Absatz 1, Ziffer 2 10c MAA-Human form § 10, Absatz 9 10(3) MAA-Human form § 10a 10a MAA-Human [...] form mit Zusatzbla tt 1.4, 1.6, 2.1.3, 2.4.4, 2.4.5, 2.5.1.b, 2.5.1.1, 2.5.1.2 § 11a - MAA-Human form mit Zusatzbla tt 1.4, 1.6, 2.4.4, 2.4.5, 2.5.1.b, 2.5.1.1, 2.5.1.2 § 12 16a MAA-Human form Informationen

Referenced at:

• National Information
• Authorisation/registration applications
• Authorisation/registration applications
• Life-Cycle
• Homeopathic Medicinal Products
• Homeopathic Medicinal Products
• Herbal Medicinal Products
• Herbal Medicinal Products
• Electronic application
• FAQ electronic Submission
• FAQ electronic Submission

41 38 21 16 16 16 14 13 13 9 9 8 7 7 7 6 6 5 5 5 4 2 1 1 0 0 0 0 0 0 0 UK DE SE NL ES IE FR AT PL IT HU BE DK NO CZ PT EE IS LV MT FI EL LT SK BG CY HR LU RO SI SI 10 20 30 40 50 19 16 16 16 16 15 12 10 [...] completed very successful. As a consequence, it has also been possible to provide the pharma- ceutical industry in Austria with a solid and competent regulatory environment, thus giving a viable basis for sustaining [...] decisions in a transparent way 2.2 Keep stakeholders proactively informed 2.3 All Under One Roof (AUOR) is known to all applicants as a unique selling proposition (USP) of AGES MEA 2 1 15 Acting in a customer-and

Referenced at:

• Annual Reports and Facts Folder

Zuschläge 2015 39 33 25 21 16 14 11 10 9 8 7 7 7 7 7 7 6 6 5 3 3 2 2 0 0 0 0 0 0 0 M S 1 M S 2 M S 3 M S 4 M S 5 A us tr ia M S 7 M S 8 M S 9 M S 10 M S 11 M S 12 M S 13 M S 14 M S 15 M S 16 M S 17 M S 18 M S 19 [...] Well-established use application (Article 10a of Directive No 2001/83/EC) 181 144 1 24 Homöopathika Homeopathic marketing authorisation procedure (Article 16 of Directive No 2001/83/EC) 639 Medizinische [...] Es wurden 2015 insgesamt 19 Enforcement-Inspektionen durchgeführt (2009: 16, 2010: 49, 2011: 52, 2012: 24, 2013: 28, 2014: 16) und 3 Anzeigen an die Straf- behörden erstattet (2009: 20, 2010: 15, 2011:

Referenced at:

• Annual Reports and Facts Folder