Articles controlled and marked by an authorised assay office in accordance with the provisions of this Convention shall not be submitted to further compulsory assaying or marking in an importing Contracting State.

Where there is evidence of repeated and grave misapplication of the Common Control Mark the importing Contracting State may temporarily refuse to accept articles bearing the assay office mark of the assay office concerned whether or not controlled and marked in accordance with this Convention.

Each Contracting State shall have and maintain legislation prohibiting, subject to penalties, any forgery, unauthorised alteration or misuse of the Common Control Mark or of the marks of the authorised assay offices which have been notified in accordance with paragraph 3 of Article 5, and any unauthorised alteration to the article or alteration or obliteration of the fineness mark or responsibility mark after the Common Control Mark has been applied.

(c) "technical specification": a specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures.

In that event, the test and trial results shall be replaced by appropriate scientific literature.

The results of other tests and trials from the reference medicinal product's dossier shall not be provided.

The results of other tests and trials from the reference medicinal product's dossier shall not be provided.

Furthermore, the period for protection of data relating to pre-clinical tests and clinical trials should be harmonised.

During the impulse and the a.c. voltage tests, the circuits which are not under test shall be connected to either the frame or the earth as indicated below.

The correlation testing shall be performed at the same laboratory, test cell, and on the same engine, and is preferred to be run concurrently.

advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products;

For type approval testing to either row B1 or B2 or row C of the tables in section 6.2.1 the emissions shall be determined on the ESC, ELR and ETC tests.

For medicinal products for veterinary use, the period for protection of data relating to pre-clinical tests and clinical trials as well as safety and residue tests should be the same as that provided for in Directive 2001/82/EC.

If further information on metabolites is sought, stepwise testing strategies should be employed to ensure maximum use of in-vitro and other non-animal test methods.

For medicinal products for human use, the period for protection of data relating to pre-clinical tests and clinical trials should be the same as that provided for in Directive 2001/83/EC.

The tests must be carried out on each meter, with the cover fitted, except for certain mechanical properties and, if necessary, for checking the register.

The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned.

The competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned.

They may subsequently be re-installed and tested in their turn with other controls that have been removed to facilitate the procedure.

All tests referred to in Articles 3 and 4 and in Annexes II, III, IV and VIII shall be conducted in compliance with the standards mentioned in Annex I.1 and in accordance with testing requirements under Article 10(5) of Regulation (EEC) No 793/93.

Since the conditions under which these tests are carried out are usually not the standard conditions for type approval, the values in Table VI below, which give more latitude, are used instead of the values set out in Tables I and II.

The notified body must perform the appropriate examinations and tests in order to check the conformity of the transportable pressure equipment with the relevant requirements of the Directive by examining and testing every product in accordance with point 4.

Conducting the necessary studies, tests and trials with a view to the application of paragraphs 1 to 5 and the consequential practical requirements shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for medicinal products.";

In the tests referred to in 8.14.1 (b), 8.14.2 and 8.14.3, the pipes are deemed gas-tight if, after sufficient time to allow for normal balancing, no fall in the test pressure is observed during the following 10 minutes.

the following subparagraph shall be added:"The documents and information concerning the results of the pharmaceutical and pre-clinical tests and the clinical trials referred to in point (i) of the first subparagraph shall be accompanied by detailed summaries in accordance with Article 12.";

The notified body must have permanent access for testing and verification purposes to the locations of design, building sites, production workshops, locations of assembling and installations, and where appropriate, prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.

Entitled to such information is any person engaged in commercially servicing or repairing, road-side rescuing, inspecting or testing of vehicles or in manufacturing or selling replacement or retro-fit components, diagnostic tools and test equipment."

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the interoperability constituent with the type as described in the type-examination certificate and with the requirements of the TSI either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of interoperability constituents on a statistical basis, as specified in point 5, at the choice of the manufacturer.

When a biological medicinal product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both.

Directive 2001/83/EC(4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type as described in the EC type-examination certificate and with the requirements of Directive 96/48/EC and the TSI by examination and testing of every subsystem, manufactured as a serial product, as specified under point 4.

In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided.

Where the applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC, he/she should not be required to provide the results of pre-clinical tests or the results of clinical trials.

Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

"Article 10 1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community.

These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling and production processes and methods.

A Member State may introduce or retain on its territory specific rules for the safety tests and pre-clinical and clinical trials of homeopathic veterinary medicinal products intended for pet species and non-food-producing exotic species other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State.

By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I.

These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, and production processes and methods.

Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the pre-clinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 5 for not less than eight years in a Member State or the Community.

If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in accordance with Regulation (EEC) No 2377/90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to Article 13, for a period of three years from the grant of the authorisation for which they were carried out.

In the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with point (j) of the first subparagraph of Article 12(3), but it shall not be necessary to provide scientific references relating to each individual active substance.

By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety and residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the applicant shall provide appropriate scientific literature.

"Technical specification", in the case of service or supply contracts, means a specification in a document defining the required characteristics of a product or a service, such as quality levels, environmental performance levels, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, use of the product, safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production processes and methods and conformity assessment procedures;

"technical specification", in the case of public supply or service contracts, means a specification in a document defining the required characteristics of a product or a service, such as quality levels, environmental performance levels, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, use of the product, safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production processes and methods and conformity assessment procedures;

Omission of any tests or trials listed in Parts 7 and 8 shall be indicated and discussed.

Types of test and test criteria

examination of Type V testing, including the possibility of abolishing it.

The whole procedure must be tested in clinical trials and described in the product information.