HARMONISATION

A first comprehensive round robin test described in 4.1 which is open to all interested parties will be followed periodically by round robin tests in a reduced extent to ensure the further harmonisation of measurement procedures. The check of measurering equipments and procedures is an inalienable requirement for the further steps for providing the users with constant film quality. Together with sample tests performed by BAM as indicated in section 4.2 and and the production control by the manufacturer it will be possible to survey the film systems whether they meet the requirements of one of the film classes of EN 584-1. 

The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

The significance of the principles applied to the new technical harmonisation directives is best understood when compared to those applied to technical harmonisation in the past. 

The earlier policy on technical harmonisation within the then European Community was to adopt directives for individual products and which set out the technical requirements in great detail. This resulted not only in a great number of directives needing to be developed but the setting out of the technical requirements in such detail proved to be a hindrance to technical progress. 

From 1985 three major changes have been introduced to do away with the disadvantages encountered with the old approach . In 1985 the European Council adopted a New Approach to technical harmonisation and standards , in 1989 it adopted the Global Approach to conformity assessment which was amended in 1993 and in 1987 the legal basis for... 

Harmonised standards are technical specifications adopted by one of the European standards organisations following a mandate issued by the European Commission on which Member States were consulted. When published by the Commission in the Official Journal of the European Communities, the hamionised standards give presumption of confomiity to the essential requirements they specify. This means that manufacturers applying these standards do not have to demonstrate the compliance of the manufactured products with the relevant requirements of the directive. 

Two main types of harmonised standards can be distinguished the product standards and the horizontal standards. The latter, as their denomination indicates, contain issues of a horizontal nature, e.g. for materials or provisions relating to welding or welder approvals. These standards should be formulated in such a way as to be self-sufficient. That means it should be possible to apply them without having to use individual product standards. 

A section related to materials sets out, apart from general requirements, that compliance with the material specifications of the directive can be achieved in one of the following forms by using materials which comply to harmonised standards, by using materials covered by a European approval of materials, a subject which will be explained further on, and by a particular material appraisal carried out by the notified body. 

Finally, under the heading Specific pressure equipment requirements specific requirements are set out for equipment with a risk of overheating, for piping and, last but not least, specific quantitative requirements which set out a series of safety factors for certain pressure equipment. These latter provisions apply as a general rule which means that a manufacturer or a harmonised standard may deviate from these factors if it can be demonstrated that appropriate measures have been taken to achieve an equivalent level of safety. 

The user inspectorate must fulfil the same technical criteria as the notified body. In addition, it must be organisationally identifiable and demonstrate its impartiality. It must not engage in any activities that might conflict with its independence of judgement and integrity. Given that the authorisation of user inspectorates to carry out conformity assessment is an innovation for technical harmonisation at Union level, the Commission shall monitor the application of this measure and evaluate its effects three years after the coming into force of the directive. 

Farley J M The role of the ECNDT in harmonisation of important links in the NDT quality chain , 1 International East-West Symposium NDT, October 1993... 

The main purposes of the System of accreditation is to ensure reproducibility of measurements, harmonisation of rules and procedures of the National system of accreditation with guidelines of international organizations and national systems of different countries, creation of conditions for mutual recognition of the results of testing, calibration, attestation. 

Comparison of the requirements and provisions of GOST 8.010-90 and terms of ISO 8402 1994 shows identity of procedures being used and we can note that these procedures are harmonised. 

We are greatlv indebted to Dr. D. K. C. Cooper, F.R.C.S., who has critically examined the section on Tirst-Aid to ensure that it now harmonises with modern medical practice. 

In November 1997, the Department of Health and Human Services along with the International Conference on Harmonisation (ICH) released a draft guidance for the selection of test procedures, which included chiral drugs. For the development of an enantiopure drug substance, acceptable criteria shall include, if possible, an enan-tioselective assay. This assay should be part of the specification for the identification of an enantiopure drug substance and related enantioenriched impurities [16]. 

International Conference on Harmonisation Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice, Fed Regist. Docket No. 97D-0448, 1997. 

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... 

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... 

There have been a number of amending directives since the base directives were issued these are summarised in Table 1.4. Directive 2007/47/EC is the most important as it contains significant amendments to all three base directives. It builds on the practical experience gained in implementing the directives, and sets out to simplify and harmonise the language of the directives so as to ensure consistent interpretation and application of the requirements in all Member States. Among other items addressed,... 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances... 

The International Conference on Harmonisation (ICH) of technical requirements for the registration of pharmaceuticals for human use was established in 1990 as a joint regulatory/industry project to improve, through harmonisation, the efficiency... 

Harmonisation activities are overseen by a steering committee comprising representatives of each of the six parties, together with observers from the WHO, the European Eree Trade Association (EFTA) and Canada. The Committee meet at least twice each year, with the location rotating between the three regions. The committee also organises major international conferences on harmonisation that are held every 2 years. 

The IC H focuses on developing harmonised guidance documents under four topic headings ... 

This should outline existing differences and suggest how harmonisation on a... 

The final draft is then presented to the Steering Committee in step 4 for adoption as an ICH Harmonised Tripartite Guideline. 

The Global Harmonisation Task Force (GHTF) was conceived in 1992 to address similar issues for medical devices. It has a broader regional base than its pharmaceutical counterparts in that it includes representatives from Canada and Australia in its core group, in addition to those from the EU, US and Japan. In some ways, it also faces a stiffer challenge in that there is more divergence in the regulatory... 

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