Agreements On Conformity Assessment And Acceptance Of Industrial Products (Acaa)

Mutual recognition of the results of compliance assessment procedures The protocol will allow Community exporters to test and certify their industrial products before being exported to the same (coordinated) requirements and to have access to this market without further compliance assessment requirements. Certification procedures must be implemented only once for both markets and according to the same requirements or standards. Recognition of certification will save money and boost exports. The system of standardization and compliance assessment by third countries, based on the experience gained during the negotiation and implementation of PECA agreements with candidate countries, aims to facilitate trade and market access in both directions, while avoiding the problems posed by the functioning of traditional PAPs. Blood or human plasma drugs, innovative therapy drugs, experimental drugs, homeopathic drugs, medicines and veterinary immunologies are not covered by this appendix. (c) “national law”: any act and enforcement practice by which Israel has aligned its legislation with EU law applicable to a given situation, risk or a specific category of industrial products; Prior to the formal opening of the ACAA negotiations, adequate infrastructure should be put in place in the partner country in the areas of standardization, accreditation, compliance assessment and metrology. Participation in European standardisation and European accreditation work under the first mechanism is part of the mutual recognition of products on the basis of the Community acquis implemented by the partner country, as it would apply to products marketed in a Member State. It allows industrial products to be put on the market in accordance with European Union procedures, without having to go through other authorisation procedures, and vice versa. One sector is currently included: Good Manufacturing Practices (BPF) for pharmaceuticals. Israel has adopted EU technical legislation in the sector covered by the annex of the protocol and participates in European organisations in the sector it covers. In order to respond to Member States` requests for safe products in the internal market, accreditation should be used to ensure the competence of notified compliance assessment bodies in ACAA countries.

The application of harmonised European standards would also be considered important, even if their use was voluntary. Therefore, 100% of the harmonised European standards should be implemented in the ACAA sectors. It would therefore be advantageous for the countries concerned to have the opportunity to incorporate these standards into their national regulatory frameworks. The second mechanism, namely the mutual recognition of manufactured products that are not generally regulated, confirms that Articles 16 and 17 of the Euro-Mediterranean Agreement with Israel apply without further restrictions in the product sectors it covers. In other words, the annexes applying this mechanism provide that industrial products listed in these annexes and legally marketed on the market of one of the contracting parties (i.e. on the territory of Israel or an EU Member State) can be legally marketed in the other party in the absence of European technical rules.





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