Annexes to COM(2017)796 - Mutual recognition of goods lawfully marketed in another Member State

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ANNEX

Mutual recognition declaration for the purposes of Article 4 of Regulation (EU) 2019/515 of the European Parliament and of the Council (1)

Part I

1. Unique identifier for the goods or type of goods: … [Note: insert the goods identification number or other reference marker that uniquely identifies the goods or type of goods]

2. Name and address of the economic operator: … [Note: insert the name and address of the signatory of Part I of the mutual recognition declaration: the producer and, where applicable, its authorised representative, or the importer, or the distributor]

3. Description of the goods or type of goods subject of the mutual recognition declaration: … [Note: the description should be sufficient to enable the goods to be identified for traceability reasons. It may be accompanied by a photograph, where appropriate]

4. Declaration and information on the lawfulness of the marketing of the goods or that type of goods

4.1.   The goods or type of goods described above, including their characteristics, comply with the following rules applicable in … [Note: identify the Member State in which the goods or that type of goods are claimed to be lawfully marketed]: … [Note: insert the title and official publication reference, in each case, of the relevant rules applicable in that Member State and reference of the authorisation decision if the goods were subject to a prior authorisation procedure],

or

the goods or type of goods described above are not subject to any relevant rules in … [Note: identify the Member State in which the goods or that type of goods are claimed to be lawfully marketed].

4.2.   Reference of the conformity assessment procedure applicable to the goods or that type of goods, or reference of test reports for any tests performed by a conformity assessment body, including the name and address of that body (if such procedure was carried out or if such tests were performed): …

5. Any additional information considered relevant to an assessment of whether the goods or that type of goods are lawfully marketed in the Member State indicated in point 4.1: …

6. This part of the mutual recognition declaration has been drawn up under the sole responsibility of the economic operator identified under point 2.

Signed for and on behalf of:

(place and date):

(name, function) (signature):

Part II

7. Declaration and information on the marketing of the goods or that type of goods

7.1.   The goods or that type of goods described in Part I are made available to end users on the market in the Member State indicated in point 4.1.

7.2.   Information that the goods or that type of goods are made available to the end users in the Member State indicated in point 4.1, including details of the date of when the goods were first made available to end users on the market in that Member State: …

8. Any additional information considered relevant to an assessment of whether the goods or that type of goods are lawfully marketed in the Member State indicated in point 4.1: …

9. This part of the mutual recognition declaration has been drawn up under the sole responsibility of … [Note: insert the name and address of the signatory of Part II of the mutual recognition declaration: the producer and, where applicable, its authorised representative, or the importer, or the distributor]

Signed for and on behalf of:

(place and date):

(name, function) (signature):



(1) Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1).