Guidance document Formal requirements HMV4:
Chapter 3.11 "Variations and extensions": inclusion of no. A.220.127.116.11 - Number of variations per variation no.
Chapter 3.20 “DMF/ASMF and Plasma Master Files” Explanation re no A.18.104.22.168 form DMF HMV4.
Chapter 3.2.1 “Recognition of orphan drug status (ODS) for human medicinal products” and Chapter 3.2.2 “Recognition of MUMS status for veterinary medicines”: Swissmedic will cancel the advance payment.
Guidance document Orphan Drug HMV4:
Chapter 6.2 “Formal aspects, documents to be submitted and examination”: Swissmedic will cancel the advance payment of the application fee.
Guidance document Time limits for authorisation applications HMV4:
Specification of Time limit categories / Application types, Modification, Type IB, Correction of documents subject to formal objection: 30 CD. Correction of the footnote 3 on page 11.
Guidance document Authorisation of human medicine with known active pharmaceutical ingredient HMV4:
Section 6.3.6: Explanation: Any differences in the active substance release profiles must be explained, along with reasons.
Section 6.3.7: Clearer wording regarding the scorability check.
Form Variations and extensions HMV4:
With regard to the templates under “C. Variations relating to safety, efficacy and pharmacovigilance”, a variation classed as “Other variation” can now only be submitted using template C.I.z.
Explanations relating to template A.4 and the templates under “B. Changes in quality”.
Form DMF HMV4:
Explanation of the procedure for submitting DMFs.
The new version of the affected document enter into force as of 05.02.2019.