Mutual Recognition of Product Standards: Regulations After 2008

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Brexit: a future so opaque Brexit: an artificial crisis. Not yet though do we see any coherence in defining an end game, other than the vague offering of a "free trade agreement" with the EU, most often expressed in terms of the EU-Canada trade deal CETA , which has yet to be ratified. But, if the interim package is to involve continued participation in the Single Market via the EEA, what none of these media geniuses are asking is why industry and commerce would accept such a transition.


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  5. Mutual recognition;

After all, the EEA Agreement offers unparalleled access to EU markets, while the Canadian deal — which is one of the most comprehensive negotiated outside the EEA — affords a very substantially reduced rights. There is no logic at all in abandoning an interim deal if the final outcome is substantially worse. One significant example I have been studying is the issue of mutual recognition — not the recognition of conformity assessment to which we have previously referred, but the mutual recognition of standards. Within EU law, this principle applies in the so-called non-harmonised sectors, where goods are not subject to common EU rules and may come under the national rules.

In that case, in the absence of a harmonising law, a Member State must allow a product lawfully produced and marketed in another Member State into its own market, even if its own local rules impose more stringent or different requirements to which the product does not conform.

As an aside, the title itself as well as the text illustrates some of the limitations of Mrs May's intention to repatriate EU law. Even if the UK adopts this law, it will have no effect on our trade relations with the EU because the principle applies to goods produced in one Member State and marketed in another. When we leave the EU, we will no longer be a Member State, so the law will not apply to us — unless special provisions are made by the EU.

When it comes to the fabled 1,page EU-Canada Agreement , the Parties merely endeavour to undertake regulatory cooperation activities that may include: … identifying the appropriate approach to reduce adverse effects of existing regulatory differences on bilateral trade and investment in sectors identified by a Party, including, when appropriate, through greater convergence, mutual recognition, minimising the use of trade and investment distorting regulatory instruments, and the use of international standards, including standards and guides for conformity assessment.

In other words, there is nothing like any blanket mutual recognition principle — not in this trade agreement nor any other. Where there is no EU harmonising law covering specific products — which accounts for about 20 percent of our trade in goods — our exporters would have to comply with the local laws of each Member State to which they send goods.

With different standards applying to different states, exporting would become somewhat complicated and considerably more expensive - increasing costs by as much as 20 percent.. Nevertheless, there are always those optimists who suggest that Member States would take a relaxed view of regulatory divergences, and would not apply local codes to UK goods. But we are unlikely to be so fortunate. Even with mutual recognition in place, a page report on the "Evaluation of the Application of the mutual recognition principle in the field of goods" for the Commission suggests that the principle "is still not achieving its objectives", particularly as the knowledge of the functioning of the principle is generally at a rather low level among companies and Member State authorities.

So problematic is its implementation that the trade body Business Europe recently complained that national standards were interfering with the free circulation of goods. The Commission, therefore, is to present an EU-wide Action Plan to raise awareness of the principle of mutual recognition, and is to revise the Mutual Recognition Regulation to improve its functioning. This is part of its strategy to strengthen the Single Market — something of which the UK will not be part.

Introduction

And there is yet another illustration — this time of the dynamic nature of the Single Market. It is subject to constant change and development, in which the UK currently participates but will no longer if we stand apart from it after Brexit. Thus, should we take advantage of the EEA-interim solution — assuming we can — the divergence between the Single Market and any free trade agreement that we can broker is likely to increase.

The idea then of using an interim arrangement to buy time to negotiate something worse then starts to look absurd. Without some serious thought, therefore, the idea of an interim solution isn't going to fly. And one of the add-ons which we will have to secure in any end game is the full application of the mutual recognition principle. Brexit: madder and madder. Brexit: it's a deal, Jim…. Brexit: a Mad Hatter's tea party.

Brexit: the limit of tolerance. Brexit: no exit on 31 October. The text of the Agreement can be found at the Global Affairs Canada website. More precisely, fourteen 14 of the original fifteen 15 Member States were included in the operational phase. With the accession of 10 new EU Member States in May 1, , it was decided that the countries would be evaluated one at a time.

Once all regulatory authorities typically one or two within a country are considered as equivalent, the country would be considered as equivalent and the operational phase would start. June 1 st , Start of operational phase for Hungary and Czech Republic. November 1 st , Start of operational phase for Malta and Cyprus. August 1 st , Start of operational phase for United Kingdom-Veterinary. Since March 1, , the regulatory authority is considered in the Operational Phase of the MRA, meaning that the exchange of Certificates of Compliance and the information on the Two-Way Alert System is shared between the Romanian human and Canadian regulatory authorities.

Fourteen 14 of the fifteen 15 original Member States of the EC are involved.

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Mechanisms across product sectors | European Free Trade Association

Luxemburg is not included in the operational phase as it does not have a GMP inspection programme. As explained under "Key Dates", ten 10 new Member States have joined on May 1 st as well as two 2 others on January 1 st , We have to evaluate and find equivalent their respective Regulatory Authority before they can be included in the following list. We will add them to the list progressively as they are found equivalent. Please note that the RA s are identified in their official language s.

If the official language is not English or French, and an English or French denomination is known or used at the international level, it is provided in " italic ". List of Regulatory Authorities by Member State:. As a result of these regulations certain products which were previously regulated as drugs medicinal products are now regulated as natural health products e.

EC Proposes Revisions to the Mutual Recognition Regulation

Due to the new NHP regulations, drug establishment licenses previously held by natural health product companies are considered expired and have not been renewed since January In order to bring these products back within the scope of the MRA , Health Canada is preparing a regulatory amendment which would allow, on a voluntary basis, Canadian natural health product companies to hold an establishment licence, issued based on compliance with pharmaceutical Good Manufacturing Practices GMP , in addition to the site licence required under the NHP Regulations.

Further information is available on the Natural Health Products website. Health Canada will update EC of any progress in this matter. As such, manufactures of these products require a manufacturing authorisation and need to comply with EU GMP. Recognising that the Canadian regulations have their own set of GMP requirements for natural health products and do not require these products to be manufactured in a facility to a GMP level equal to those for drugs, many companies do ensure this level of manufacture.

A Canadian drug establishment license will not be issued in these cases, as it is not required by Canadian Law.