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Characteristics

The legal basis

Mutual Recognition finds its legal basis in Chapter VII of the BPR. Article 34 in particular focuses on mutual recognition in parallel, while art. 35 focuses on mutual recognition in sequence.

In certain cases, risk assessments and authorisations in the Netherlands may deviate from those in the EU because of specifically Dutch circumstances or legislation. For more information see National Specific Issues (Chapter 3. The Application of national specific elements).

Application type criteria

Prior condition for a Mutual recognition of a national authorisation :

  • The active substances in the product have been approved for the relevant product-type and any conditions specified for those active substances are met; (BPR (EU) 528/2012, art. 19). You can check this in the list of approved substances.
  • For mutual recognition in sequence: the reference product has been authorised under the BPR (EU) 528/2012 (or BPD 98/8/EC)
  • For mutual recognition in parallel: the application for mutual recognition must be submitted at the same time as the application for national authorisation in the reference member state

Duration of the product authorisation

When an authorisation by mutual recognition is granted, the expiry date will be identical to the expiry date of the reference authorisation.

Information requirements

For an application for Mutual recognition in sequence/in parallel in the Member States concerned, an IUCLID dossier is not required. Nevertheless, an IUCLID dossier must be submitted with the initial National authorisation application to the reference MS.

Article 20-21 of the BPR lists the requirements for an application for a national authorisation of a biocidal product.

Documents to be provided with the application for mutual recognition are:

  • Letter of Access to the active substance data that is valid for the member state in which mutual recognition is applied for
  • SPC in the official language of the country in which mutual recognition is applied for. For mutual recognition in sequence and should be an exact translation of the SPC of the reference member state.
  • For mutual recognition in parallel, the SPC is first provided in English as to the reference member state. Once there is agreement on the SPC, an translation in the official language of the country in which mutual recognition is applied for should be provided.

With regard to practical information for this type of application on characteristics, BPR requirements and best practices to fulfil them, see ECHA’s Practical Guides on BPR – Mutual recognition.