Division 2 Obligations of the Parties

For products covered by this Annex, each Party shall recognise the conclusions of inspections of compliance of manufacturers and importers with the principles and guidelines of EU GMP and equivalent Israeli GMP carried out by the relevant inspection services of the other Party on its own territory or in a third country in compliance with provisions on inspections as documented through the granting or refusal to grant a GMP certificate. The relevant provisions are listed in Section I.

For medicinal products covered by this Annex, each Party shall recognise the relevant manufacturing and import authorisations confirming compliance with legislation on manufacture and importation and with the principles and guidelines on EU GMP and equivalent Israeli GMP.

Certification of the conformity of each batch to its specifications by either the manufacturer established in one of the Parties, or the importer, shall be recognised by the other Party without re-control at import from one Party to the other. However, the additional responsibilities of the qualified person or the responsible pharmacist of the importer in each Party, with respect to the certification of each batch as set out in Section I above, remain in accordance with the provisions of the EU and Israeli national laws set out in Section I.

The provisions in points (a), (b) and (c) shall apply to finished or intermediate medicinal product imported from a third country and further exported to the other Party, only (1) if each batch of the medicinal product has been subject to re-control by either the importer from a third country or a manufacturer located in one of the Parties and (2) if the manufacturer in the third country has been subject to an inspection by the competent authority of either Party of which the outcome has been that for the product or product category the manufacturer complies with Good Manufacturing Practice.

However, the provisions in points (a), (b) and (c) do not apply to products imported from a third country, that have exclusively been tested in and inspected by a competent authority of that or another third country. Any derogation from this provision on the basis of an agreement by one Party similar in effect to this Protocol, or any unilateral concessions by one Party to a third country or party having a similar effect to an agreement of this type shall be subject to the consent of the other Party.

When one party requires a competent authority or an Official Medicines Control Laboratory to carry out an Official Control Authority Batch Release, such checks carried out by an authority of a Party will be recognised as valid by the other Party through certificates documenting compliance with specifications laid down in the marketing authorisation.

Each Party will ensure that each product batch exported to the other Party will be accompanied by a batch certificate. Batch certificates for medicinal products will be duly signed by the qualified person or responsible pharmacist of the manufacturer or importer of the appropriate Party.