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Guidance on Variations, Extensions, Doc Protections, Form & Criteria Annex – Swissmedic -HMV4

Swismedic released multiple Guidance documents on 1st august, 2021 and are as follows

1. Guidance document Variations and extensions HMV4

This guidance document explains the requirements pertaining to variations and extensions for human and veterinary medicinal products. Annex 7 TPLRO (List of variations as per Arts. 21–24 TPO) provides a list of all variations of types IA/IAIN, IB, and II and the extensions that are relevant for Switzerland and for which Swissmedic is responsible.

The annex is structured as follows:

A. Regulatory changes

B. Quality changes

C. Safety, efficacy and pharmacovigilance changes

X. Changes to Plasma Master Files (PMF)

Y. Various changes relating to complementary and herbal medicines

Z. Extensions

This guidance document applies to the Authorisation, Licensing and Market Surveillance divisions of Swissmedic for applications for a change and/or extension relating to human and veterinary medicinal products received by Swissmedic from the effective date of the revised Therapeutic Products Act (TPA).

2. Guidance document Criteria Annexes 4–10 KPTPO HMV4

This guidance document describes the requirements that a substance (or standard work in the case of Annex 9 KPTPO) must fulfil to qualify for inclusion in or addition to the lists in Annexes 4 to 10 KPTPO (Ordinance of the Swiss Agency for Therapeutic Products of 7 September 2018 on the Simplified Licensing of Complementary and Phytotherapeutic Products).

3. Guidance document Description of document protection HMV4

The guidance document describes the rules for granting and managing DP, as well as the associated rights and obligations for the marketing authorisation holder. As this is a guidance document aimed at administrative bodies, it does not directly specify the rights and obligations of private individuals. Swissmedic uses this document first and foremost as a resource for applying the legal provisions on authorisation in a uniform and equitable manner.

The publication of the guidance document is designed to make it clear to third parties what requirements must be fulfilled according to the practice of Swissmedic.

the guidance document applies to applications for new authorisation, for authorisation extension and for variation of the indications and dosage recommendations for human and veterinary medicinal products which are received by Swissmedic from 1 January 2019.

4. Form for New authorisation of human medicinal products HMV4

Updated form is New authorisation of human medicinal products HMV4 is released for upcoming submissions.


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