Legislator Case Law & Legislation
DE FR IT EN
Analyze in Legislator
812.21 HMGLPTHLATER CH AI generated

Art. 95 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Transitional provisions

TPA; Chapter 9 Final Provisions
Open official source Full Act (141 Articles) Machine-readable Markdown (.md)

Legislator summary

AI generated

Registrations of medicinal products carried out by the FOPH, the FSVO and by the Intercantonal Office for the Control of Medicinal Products remain valid for up to five years after the commencement of this Act. Cantonal authorisations for medicinal products are valid until 31 December 2017; medicinal products may be authorised by the Agency within two years of the expiry of the transitional period. {note: Amended by No I of the FA of 21 June 2013, in force since 1 Jan. 2014 ( AS 2013 4137; BBl 2013 3281 3289).} The foregoing is without prejudice to: a. the revocation of an authorisation by the canton; b. the replacement, on request, of a cantonal authorisation by a marketing authorisation issued by the Agency. Requests for a marketing authorisation for medicinal products for which no authorisation was previously required either under cantonal or federal legislation, but which must be authorised under this Act must be submitted within one year of the commencement of this Act. Medicinal products may continue to be placed on the market until the Agency has reached a decision. In vitro diagnostics may be placed on the market in accordance with the former Act until 7 December 2003. Licences and registrations of in vitro diagnostics established in accordance with the former Act shall be valid until the expiration of their validity period or for a maximum of three years from the commencement of this Act. Authorisations issued by the Confederation and by the cantons in accordance with the former Act are valid until the expiry of their validity period or for a maximum of five years from the commencement date of this Act. Persons who do not satisfy the provisions relating to the dispensing of medicinal products (Articles 24 and 25) must cease to dispense them within seven years from the commencement of this Act. The Federal Council may, however, issue exemptions for persons who can prove that they have sufficient education and training. The administrative measures taken by the Agency and referred to in Article 66 are reserved.

Art. 95 TPA · Transitional provisions

Registrations of medicinal products carried out by the FOPH, the FSVO and by the Intercantonal Office for the Control of Medicinal Products remain valid for up to five years after the commencement of this Act.

Cantonal authorisations for medicinal products are valid until 31 December 2017; medicinal products may be authorised by the Agency within two years of the expiry of the transitional period. The foregoing is without prejudice to: a. the revocation of an authorisation by the canton; b. the replacement, on request, of a cantonal authorisation by a marketing authorisation issued by the Agency.

Requests for a marketing authorisation for medicinal products for which no authorisation was previously required either under cantonal or federal legislation, but which must be authorised under this Act must be submitted within one year of the commencement of this Act. Medicinal products may continue to be placed on the market until the Agency has reached a decision.

In vitro diagnostics may be placed on the market in accordance with the former Act until 7 December 2003. Licences and registrations of in vitro diagnostics established in accordance with the former Act shall be valid until the expiration of their validity period or for a maximum of three years from the commencement of this Act.

Authorisations issued by the Confederation and by the cantons in accordance with the former Act are valid until the expiry of their validity period or for a maximum of five years from the commencement date of this Act.

Persons who do not satisfy the provisions relating to the dispensing of medicinal products (Articles 24 and 25) must cease to dispense them within seven years from the commencement of this Act. The Federal Council may, however, issue exemptions for persons who can prove that they have sufficient education and training.

The administrative measures taken by the Agency and referred to in Article 66 are reserved.

← Art. 94 TPA Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Purpose Art. 95a TPA →

Need to analyze how this provision applies to your matter?

Cross-reference this statute against case law, commentaries, and related legislative provisions inside Legislator AI.

Open in Legislator →

Court Decisions Applying This Provision (9)

C-4687/2010 (art. 95 cpv. 3 LATer)
Anesthetic Homologation Denied Due to Insufficient Safety Evidence
Cited as the legal basis under which the 'G._______' preparation could remain on the market until a final decision was made.
C-7594/2008 (Art. 95 cpv. 3 LATer)
Marketing Authorization Appeal for Carbon Dioxide Local Anesthetic
Cited to establish that the medicinal product could remain on the market until a decision on its approval was made.
C-6903/2009 (Art. 95 Abs. 3 HMG)
Compressed Oxygen Inhalation Gas Market Authorization Refused
Provision concerning the continued marketing of a drug until a decision on approval is made.
C-2261/2006 (Art. 95 cpv. 3 LATer)
Swissmedic Denies Local Anesthetic Registration Due to Safety Concerns
This provision governed the applicant's initial request for marketing authorization for a medication that was not previously subject to approval.
JAAC 70.21 (Art. 95 al. 3 HMG)
Inhalation Gas Price Hike and Agency Press Release Litigation
Cited in relation to the potential for manufacturers to be confirmed in their right to market specialties without a marketing authorization even after the transitional period.
JAAC 69.21 (Art. 95 Abs. 1 HMG)
Drug Quality Deficiencies Lead to Marketing Authorization Refusal
This provision allowed IKS registrations to remain valid for a maximum of 5 years after the entry into force of the HMG, setting the timeframe for the conversion process.
JAAC 67.93 (Art. 95 Abs. 5 HMG)
Pharmaceutical Importation and Formula Magistralis Exemption
Allows existing cantonal authorizations to remain valid for a transitional period after the HMG came into effect.
JAAC 67.58 (Art. 95 Abs. 1 HMG)
Herbal Medicine Labeling: Drug-to-Extract Ratio Upheld
Regulates the transitional period for existing registrations, which was relevant when considering the timing of applying new information requirements to older products.
JAAC 67.31 (Art. 95 Abs. 1 HMG)
*Novartis AG v. European Medicines Agency*
This provision is cited concerning the validity of registrations made under previous regulations, indicating its procedural relevance in the transition to the new law.