Revision of the Therapeutic Products Act and amendments to ordinances

swissmedic-specials_hmv4-intro

21.09.2018

Therapeutic Products Ordinance Package IV: Publication of the ordinances

The Federal Council has approved Therapeutic Products Ordinance Package IV. Swissmedic and the FOPH publish the revised documents.

15.08.2018

Revision des Heilmittelgesetzes (HMG)

Informationsveranstaltung 2018

23.05.2018

Reclassification of medicinal products: status update

Project to reclassify medicinal products in other dispensing categories in connection with the revision of the Therapeutic Products Act.

Background

With the ordinary revision of the TPA (Stage 2, TPA2), the legislator aims to improve the public access to medicines and the general environment for biomedical research and industry. The Federal Council referred the Dispatch on the Revision of the Therapeutic Products Act to Parliament on 7 November 2012. The National Council and Council of States adopted the core elements of the Federal Council's draft, with certain changes, and approved the revised Therapeutic Products Act in the final vote on 18 March 2016.

Because of the numerous amendments to the Act, the relevant ordinances also need to be comprehensively amended. Individual provisions (national recommendations on dosages of paediatric medicinal products, definitive arrangements for medicinal products approved by cantons) and the corresponding ordinance terms already entered into force at the beginning of 2018. The Medicinal Products Licensing Ordinance (MPLO) is being revised in the context of the drafting of the provisions for implementing the Medicrime Convention.

A consultation procedure for the remaining implementing provisions (Therapeutic Products Ordinance Package IV) was carried out from 21 June to 20 October 2017. This work affects ordinances issued both by the Federal Council and the Agency Council of Swissmedic. Feedback from the consultation procedure is currently being assessed.

According to the current schedule, the revised Act and the ordinances – with the exception of the Ordinance on Integrity and Transparency for Therapeutic Products – should enter into force on 1 January 2019.

Aims

The latest revision of the Act and the newly proposed amendments to the implementing regulations are aligned to the following aims:

  • Facilitating market access
    • Create new, simplified authorisation options for certain medicinal product categories (especially medicinal products authorised in an EU or EFTA country, medicinal products with traditional uses, medicinal products already approved in a canton, as well as various medicinal products used in complementary medicine)
    • simplify self-medication by modifying the allocation of the medicinal products to the different supply categories, and ease the supply requirements.
  • Improving drug safety
    • Tighten up and modernise market surveillance (introduce the pharmacovigilance plan, apply Good Vigilance Practice, increase the scope and define the reporting obligations in more detail)
    • improve the safety of medicinal products used in paediatrics (publish a directory for off-label dosage recommendations for the medicinal products used in paediatrics, establish new obligations and incentives for the pharmaceutical industry to promote the development of paediatric medicinal products)
    • define minimum requirements for the prescription of medicinal products.
  • Increasing transparency
    • Increase the scope of information published about the medicinal products submitted to Swissmedic for assessment and their authorisation holders (particularly publication of the assessment reports for human medicinal products with new active substances on which the authorisation decisions are based [SwissPAR])
    • clarify the arrangements regarding pecuniary benefits (integrity and transparency) and strengthen the implementation of these provisions as well as the obligation to pass on discounts in accordance with health insurance legislation
    • create an information system for monitoring the distribution and use of antibiotics and the antibiotic resistance situation in veterinary medicine.

Dates & events

Date Information/Topics  

30.09.2018

Go-live/publication of new specification documents

 

25.10.2018

Swissmedic information event on the revision of the Therapeutic Products Act (TPA)

Thursday 25 October 2018

Morning

  • Harmonisation of "variations" with EU variations
  • Reallocation of products to dispensing categories
  • Transitional rules
  • New provisions with regard to Art. 13 TPA
  • Implementation of Art. 14 para. 1 let. abis-quater


Afternoon

  • Parallel session 1 Paediatric investigation plan, temporary authorisations, document protection and orphan drugs
  • Parallel session 2 Rules for veterinary medicinal products
  • Parallel session 3 Rules for complementary and herbal medicines
Congress Centre Kursaal Bern
01.11.2018 Go-live/publication of amended eCTD M1 specifications  

09.11.2018

Swissmedic information event on the revision of the Therapeutic Products Act (TPA)

Friday 9 November 2018

Morning

  • Swiss Public Assessment Report (SwissPAR) and Public Summary SwissPAR: publication, receipt of application and authorisation decisions
  • Full declaration, new templates for patient information and information for healthcare professionals, black triangle, Italian information for healthcare professionals, publication of product information
  • Redesign of forms, Internet lists


Afternoon

  • Revision of the Medicinal Products Licensing Ordinance (MPLO): introduction in law
  • Revision of MPLO, part 1: definitions, licence types, requirements for RP
  • New establishment licences, new GMP/GDP certificates
  • Revision of MPLO, part 2: individual import licences, special licences, compassionate use
Congress Centre Kursaal Bern
2019 Most of the provisions of the TPA and the relevant implementing provisions are to enter into force as originally planned on 1 January 2019. The Federal Council shall determine the date when the provisions come into force.  
: Key dates & events

Q&A


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"Access to medicines is to be made easier from 2019, but will remain safe."

Last modification 21.09.2018

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