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  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
Home PMC and Biocides Biocides Marketing authorisation

Marketing authorisation

The marketing authorisation of a biocidal product can be obtained only when all the active substances are included in the Annexes I or IA for the PT of interest. Hence, if the inclusion in the annexes regards a PT describing an intended use different from the one of the product, it is not possible to authorise the product for its placing on the market.
The marketing authorisation procedure is described in the Decreto Legislativo n. 174 of the 25th of February 2000, implementation of the Directive 98/8/EC.

Different potential types of authorisations have been established:

Authorisation: marketing authorisation of a biocidal product for which the active substances are included in the Annex I
Registration: marketing authorisation of a “low risk biocidal product” for which the active substances are included in the Annex IA
Authorisation/Registration by Mutual Recognition Procedure (MRP): marketing authorisation/registration of a biocidal product previously authorised/registered in a Reference Member State (RMS) according to the European procedure MRP
“Frame-formulation” authorisation: marketing authorisation of biocidal products for which the “frame-formulation” concept is usable
Provisional authorisation: marketing authorisation obtainable when the biocidal product contains “new substances”, which do not belong to the Annexes I, IA or IB and not present on the market before the 14th of May 2000
The timing for obtaining the marketing authorisations strictly depends on the type of authorisation required.

When a company intends to maintain a specific PMC on the market for which the active substance has been included in the Annex I, there are two possibilities to follow:

submit the application to the Italian Ministry of Health for the marketing authorisation, within the date of inclusion of the active substance in the Annexes I or IA
submit to the Italian Ministry of Health a letter of intent with the intention to authorise the product in Italy in the near future, by applying the Mutual Recognition Procedure. This is possible as soon as the first authorisation is released by the Reference Member State (RMS). The letter of intent must be submitted within the date of inclusion of the active substance.

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