on mutual recognition in relation to conformity assessment between the European Community and New Zealand
THE EUROPEAN COMMUNITY and the GOVERNMENT OF NEW ZEALAND, hereinafter referred to as ‘the Parties’,
CONSIDERING the traditional links of friendship that exist between them,
CONSIDERING their shared commitment to promoting the enhancement of product quality, with a view to ensuring the health, safety and environment of their citizens,
DESIRING to conclude an agreement providing for the mutual recognition of the respective conformity assessment procedures required for market access to the territory of the Parties,
TAKING INTO ACCOUNT the improved conditions of trade between the Parties which the mutual recognition of test reports and certificates of conformity will bring about,
AWARE of the positive contribution that mutual recognition can have in encouraging greater international harmonisation of standards and regulations,
NOTING the close relationship between New Zealand and Australia as confirmed in the Australian and New Zealand Closer Economic Relations Trade Agreement and the Trans-Tasman Mutual Recognition Arrangement as well as the growing level of integration of the New Zealand and Australian conformity assessment infrastructures through the Agreement concerning the establishment of the Council of the Joint Accreditation System of Australia and New Zealand (JAS-ANZ),
NOTING the close relationship between the European Community and Iceland, Liechtenstein and Norway through the Agreement on the European Economic Area, which makes it appropriate to consider the conclusion of a parallel mutual recognition agreement between New Zealand and these countries equivalent to this Agreement,
BEARING IN MIND their status as Contracting Parties to the Agreement establishing the World Trade Organisation, and conscious in particular of their obligations under the World Trade Organisation Agreement on Technical Barriers to Trade,
1. General terms used in this Agreement and its Annexes shall have the meaning given in the definitions contained in ISO/IEC Guide 2 (1991) ‘General terms and their definitions concerning standardisation and related activities’ and in EN 45020 (1993 edition) unless the context requires otherwise. In addition, the following terms and definitions shall apply for the purpose of this Agreement:
‘Conformity assessment’ means systematic examination to determine the extent to which a product, process or service fulfils specified requirements;
‘Conformity assessment body’ means a body whose activities and expertise include performance of all or any stage of the conformity assessment process;
‘Designation’ means the authorisation by a designating authority of a conformity assessment body to perform conformity assessment activities; ‘designated’ has a corresponding meaning;
‘Designating authority’ means a body with the legal power to designate, suspend or withdraw designation of conformity assessment bodies under its jurisdiction.
2. The terms ‘conformity assessment body’ and ‘designating authority’ apply
to other bodies and authorities with corresponding functions referred to in some Sectoral Annexes.
1. The Government of New Zealand shall accept attestations of conformity including test reports, certificates, authorisations and marks of conformity as required by legislation and regulations identified in the Sectoral Annexes issued by designated conformity assessment bodies in the European Community in accordance with this Agreement.
2. The European Community shall accept attestations of conformity including test reports, certificates, authorisations and marks of conformity as required by legislation and regulations identified in the Sectoral Annexes, issued by designated conformity assessment bodies in New Zealand in accordance with this Agreement.
3. This Agreement shall not entail mutual acceptance of the standards or technical regulations of the Parties or mutual recognition of the equivalence of such standards or technical regulations.
1. This Agreement concerns the conformity assessment procedures to satisfy mandatory requirements covered by the Sectoral Annexes.
2. Each Sectoral Annex shall, in general, contain the following information:
(a) a statement of its scope and coverage;
(b) the legislative, regulatory and administrative requirements pertaining to the conformity assessment procedures (Section I);
(c) a list of the designated conformity assessment bodies (Section II);
(d) the designating authorities (Section III);
(e) a set of procedures for the designation of conformity assessment bodies (Section IV), and
(f) additional provisions as required (Section V).
1. This Agreement shall apply to products originating in the parties to the Agreement according to the non-preferential rules of origin.
2. In case of conflicting rules, the non-preferential rules of the party on whose territory the goods are marketed are determinative.
3. To the extent that the products referred to in paragraph 1 are also covered in a Sectoral Annex to the Agreement on Mutual Recognition in relation to conformity assessment between the European Community and Australia, this Agreement shall also apply to products of Australian origin.
4. To the extent that the products referred to in paragraph 1 are also covered in a Sectoral Annex to an Agreement on Mutual Recognition in relation to conformity assessment between New Zealand and States contracting parties to both the Convention of the European Free Trade Association (EFTA) and the Agreement on the European Economic Area (EEA), this Agreement shall also apply to products originating in any of these EFTA States.
Conformity assessment bodies
In accordance with the terms of the Annex and the Sectoral Annexes, each Party recognises that the conformity assessment bodies designated by the other Party fulfil the conditions of eligibility to assess conformity in relation to their requirements as specified in the Sectoral Annexes. In designating such bodies, the Parties shall specify the scope of the conformity assessment activities for which they have been designated.
1. The Parties shall ensure that the designating authorities responsible for designating the conformity assessment bodies specified in the Sectoral Annexes shall have the necessary power and competence to designate, suspend, remove suspension and withdraw the designation of such bodies.
2. In making such designations and withdrawals, designating authorities shall, unless specified otherwise in the Sectoral Annexes, observe the procedures for designation set out in Article 12 and the Annex.
3. In case of suspension of a designation or removal of such a suspension, the designating authority of the Party concerned shall immediately inform the other Party and the Joint Committee. Conformity assessment carried out by a suspended conformity assessment body before its suspension shall remain valid unless otherwise determined by its designating authority.
Verification of designation procedures
1. The Parties shall exchange information concerning the procedures used to ensure that the designated conformity assessment bodies under their responsibility and specified in the Sectoral Annexes comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex.
2. The Parties shall compare methods used to verify that the designated conformity assessment bodies comply with the legislative, regulatory and administrative requirements outlined in the Sectoral Annexes and the competence requirements specified in the Annex. Existing systems for the accreditation of conformity assessment bodies in the two Parties may be used for such comparison procedures.
3. Such comparison shall be carried out in accordance with the procedures to be determined by the Joint Committee established under Article 12.
Verification of compliance of conformity assessment bodies
1. Each Party shall ensure that conformity assessment bodies designated by a designating authority will be available for verification of their technical competence and compliance with other relevant requirements.
2. Each Party has the right to contest the technical competence and compliance of conformity assessment bodies under the jurisdiction of the other Party. This right will be exercised under exceptional circumstances only.
3. Such contestation has to be justified in an objective and argued manner and in writing to the other Party and the Chair of the Joint Committee.
4. Where the Joint Committee decides that verification of technical competence or compliance is required, it will be carried out in a timely manner jointly by the Parties with the participation of the relevant designating authorities.
5. The result of this verification will be discussed in the Joint Committee with a view to resolving the issue as soon as possible.
6. Except when decided otherwise by the Joint Committee, the contested conformity assessment body, where it is included in Section II of a Sectoral Annex, shall be suspended by the competent designating authority from the time disagreement has been established in the Joint Committee until agreement has been reached in the Joint Committee on the status of that Body.
1. The Parties shall exchange information concerning the implementation of the legislative, regulatory and administrative provisions identified in the Sectoral Annexes.
2. Consistent with their obligations under the World Trade Organisation Agreement on Technical Barriers to Trade, each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall, except where considerations of safety, health and environmental protection warrant more urgent action, notify the other Party of the new provisions at least 60 days before their entry into force.
Uniformity of conformity assessment procedures
In the interests of promoting a uniform application of the conformity assessment procedures provided for in the laws and regulations of the Parties, the designated conformity assessment bodies shall take part, as appropriate, in coordination and comparison exercises conducted by each of the Parties in the relevant areas covered by the Sectoral Annexes.
Agreements with other countries
The Parties agree that mutual recognition agreements concluded by either Party with a country which is not a party to this Agreement shall in no way entail an obligation upon the other Party to accept test reports, certificates, authorisations and marks of conformity issued by conformity assessment bodies in that third country, save where there is an express agreement between the Parties.
1. A Joint Committee made up of representatives of the two Parties shall be established. It is responsible for the effective functioning of the Agreement.
2. The Joint Committee shall determine its own rules of procedure. It shall take its decisions and adopt its recommendations by consensus. It can decide to delegate specific tasks to subcommittees.
3. The Joint Committee shall meet at least once a year unless it decides otherwise. If required for the effective functioning of this Agreement, and at the request of either Party, an additional meeting or meetings shall be held.
4. The Joint Committee may consider any matter related to the functioning of this Agreement. In particular, it shall be responsible for:
(a) amending the Sectoral Annexes to give effect to the decision by a designating authority to designate a particular conformity assessment body;
(b) amending the Sectoral Annexes to give effect to the decision by a designating authority to withdraw designation of a particular conformity assessment body;
(c) exchanging information concerning the procedures used by either Party to ensure that the conformity assessment bodies specified in the Sectoral Annexes maintain the necessary level of competence;
(d) in accordance with Article 8, appointing a joint team or teams of experts to verify the technical competence of a conformity assessment body and its compliance with other relevant requirements;
(e) exchanging information and notifying the Parties of modifications of legislative, regulatory and administrative provisions referred to in the Sectoral Annexes including those which require modification of the Sectoral Annexes;
(f) resolving any questions relating to the application of this Agreement and its Sectoral Annexes, and
(g) facilitating the extension of this Agreement to further sectors.
5. Any amendments to Sectoral Annexes made in accordance with the provisions of this Article shall be notified promptly in writing by the Chair of the Joint Committee to each Party.
6. The following procedure shall apply in relation to the inclusion in or withdrawal from a Sectoral Annex of a conformity assessment body:
(a) a Party proposing an amendment to a Sectoral Annex to give effect to a decision by a designating authority to designate or withdraw designation of a conformity assessment body shall forward its proposal to the other Party in writing, adding supporting documentation to the request;
(b) a copy of the proposal and documentation shall be sent to the Chair of the Joint Committee;
(c) in the event that the other Party consents to the proposal or upon the expiry of 60 days without an objection having been lodged, the inclusion in or withdrawal from the Sectoral Annex of the conformity assessment body shall take effect, and
(d) in the event that, under Article 8, the other Party contests the technical competence or compliance of a conformity assessment body within the aforementioned 60-day period, the Joint Committee may decide to carry out a verification of the body concerned, in accordance with that Article.
7. In the event that a designated conformity assessment body is withdrawn from a Sectoral Annex, conformity assessment carried out by that conformity assessment body before the date of effect of its withdrawal shall remain valid unless otherwise determined by the Joint Committee. In the case of the inclusion of a new conformity assessment body, conformity assessment carried out by such a conformity assessment body shall be valid from the date the Parties agree to its inclusion in the Sectoral Annex.
8. Where a Party introduces new or additional conformity assessment procedures affecting a sector covered by a Sectoral Annex, the Joint Committee shall, unless the Parties agree otherwise, bring such procedures within the mutual recognition implementing arrangements established by this Agreement.
This Agreement shall apply, as regards the European Community, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty and, as regards New Zealand, this Agreement shall not apply to Tokelau unless the Parties have exchanged Notes agreeing the terms on which this Agreement shall apply.
Entry into force and duration
1. This Agreement shall enter into force on the first day of the second month following the date on which the Parties have exchanged Notes confirming the completion of their respective procedures for the entry into force of this Agreement.
2. Either Party may terminate this Agreement by giving the other Party six months' notice in writing.
1. The Annex to this Agreement forms an integral part thereof.
2. Any amendment to this Agreement shall be done by mutual agreement.
3. The Parties shall conclude Sectoral Annexes, to which Article 2 applies, which will provide the implementing arrangements for this Agreement.
4. Amendments to the Sectoral Annexes shall be determined by the Parties through the Joint Committee.
5. This Agreement and the Sectoral Annexes are drawn up in two originals in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic.
Hecho en Wellington, el veinticinco de junio de mil novecientos noventa y ocho.
Udfærdiget i Wellington den femogtyvende juni nitten hundrede og otteoghalvfems.
Geschehen zu Wellington am fünfundzwanzigsten Juni neunzehnhundertachtundneunzig.
Έγινε στο Ουέλλιγκτον, στις είκοσι πέντε Ιουνίου χίλια εννιακόσια ενενήντα οκτώ.
Done at Wellington on the twenty-fifth day of June in the year one thousand nine hundred and ninety-eight.
Fait à Wellington, le vingt-cinq juin mil neuf cent quatre-vingt-dix-huit.
Fatto a Wellington, addì venticinque giugno millenovecentonovantotto.
Gedaan te Wellington, de vijfentwintigste juni negentienhonderd achtennegentig.
Feito em Wellington, em vinte e cinco de Junho de mil novecentos e noventa e oito.
Tehty Wellingtonissa kahdentenakymmenentenäviidentenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.
Som skedde i Wellington den tjugofemte juni nittonhundranittioåtta.
For Det Europæiske Fællesskab
Für die Europäische Gemeinschaft
Για την Ευρωπαϊκή Κοινότητα
For the European Community
Pour la Communauté européenne
Voor de Europese Gemeenschap
Euroopan yhteisön puolesta
På Europeiska gemenskapens vägnar
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PROCEDURES FOR THE DESIGNATION AND MONITORING OF CONFORMITY ASSESSMENT BODIES
A. GENERAL REQUIREMENTS AND CONDITIONS
Designating authorities shall only designate legally identifiable entities as conformity assessment bodies.
Designating authorities shall only designate conformity assessment bodies able to demonstrate that they understand, have experience relevant to, and are competent to apply the conformity assessment requirements and procedures of the legislative, regulatory and administrative provisions of the other Party for which they are designated.
Demonstration of technical competence shall be based on:
— technological knowledge of the relevant products, processes or services,
— understanding of the technical standards and the general risk protection requirements for which designation is sought,
— experience relevant to the applicable legislative, regulatory and administrative provisions,
— the physical capability to perform the relevant conformity assessment activity,
— an adequate management of the conformity assessment activities concerned, and
— any other circumstance necessary to give assurance that the conformity assessment activity will be adequately performed on a continuous basis.
The technical competence criteria shall be based on internationally-accepted documents supplemented by specific interpretative documents developed as appropriate from time to time.
The Parties shall encourage harmonisation of designation and conformity assessment procedures through cooperation between designating authorities and conformity assessment bodies by means of coordination meetings, participation in mutual recognition arrangements, and working group meetings. Where accreditation bodies participate in the designation process they should be encouraged to participate in mutual recognition arrangements.
B. SYSTEM TO DETERMINE CONFORMITY ASSESSMENT BODIES' COMPETENCE
The designating authorities may apply the following processes to determine the technical competence of conformity assessment bodies. If necessary, a Party will indicate to the designating authority the possible ways to demonstrate competence.
Accreditation shall constitute a presumption of technical competence in relation to the requirements of the other Party when:
(i) the accreditation process is conducted in conformance with the relevant international documentation (EN 45000 series or ISO/IEC guides), and either
(ii) the accreditation body participates in mutual recognition arrangements where they are subject to peer evaluation which involves evaluation by individuals with recognised expertise in the field of the work being evaluated, of the competence of accreditation bodies and conformity assessment bodies accredited by them; or
(iii) the accreditation bodies, operating under the authority of the designating authority, take part in accordance with procedures to be agreed in comparison programmes and exchanges of technical experience in order to ensure the continued confidence in the technical competence of the accreditation bodies and conformity assessment bodies. Such programmes may include joint assessments, special cooperation programmes or peer evaluation.
When a conformity assessment body is only accredited to evaluate a product, process or service for compliance with particular technical specifications, designation shall be limited to those technical specifications.
When a conformity assessment body seeks designation to evaluate a particular product, process or service for compliance with essential requirements, the accreditation process shall incorporate elements which will permit assessment of the capability (technological knowledge and understanding of the generally stated risk protection requirements of the product, process or service or their use) of the conformity assessment body to evaluate compliance with those essential requirements.
When appropriate accreditation is not available or when special circumstances apply, the designating authorities shall require the conformity assessment bodies to demonstrate their competence through other means such as:
— participation in regional/international mutual recognition arrangements or certification systems,
— regular peer evaluations,
— proficiency testing, and
— comparisons between conformity assessment bodies.
C. EVALUATION OF THE DESIGNATION SYSTEM
Once the designation systems to evaluate the competence of conformity assessment bodies have been defined by each Party, the other Party may, in consultation with the designating authorities, check that the systems give sufficient assurance that the designation of the conformity assessment bodies satisfies its requirements.
Designating authorities shall consult the conformity assessment bodies within their jurisdiction in order to determine their willingness to be designated under the terms of this Agreement. Such consultations should include those conformity assessment bodies who do not operate under the respective legislative, regulatory and administrative requirements of their own Party but which may, nevertheless, be interested and capable of working to the legislative, regulatory and administrative requirements of the other Party.
Designating authorities shall inform their Party's representatives on the Joint Committee, established under Article 12 of this Agreement, of the conformity assessment bodies to be included in or withdrawn from Section II of the Sectoral Annexes. Designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with the provisions of this Agreement and the rules of procedure of the Joint Committee.
When advising their Party's representative on the Joint Committee established under this Agreement, of the conformity assessment bodies to be included in the Sectoral Annexes, the designating authority shall provide the following details in respect of each conformity assessment body:
(c) the facsimile (fax) number;
(d) the range of products, processes, standards or services it is authorised to assess;
(e) the conformity assessment procedures it is authorised to carry out, and
(f) the designation procedure used to determine competence.
Designating authorities shall maintain, or cause to maintain, ongoing surveillance over designated conformity assessment bodies by means of regular audit or assessment. The frequency and nature of such activities shall be consistent with international best practices or as agreed by the Joint Committee.
Designating authorities shall require designated conformity assessment bodies to participate in proficiency testing or other appropriate comparison exercises where such exercises are technically possible within reasonable cost.
Designating authorities shall consult as necessary with their counterparts to ensure the maintenance of confidence in conformity assessment processes and procedures. This consultation may include joint participation in audits related to conformity assessment activities or other assessments of designated conformity assessment bodies, where such participation is appropriate and technically possible within reasonable cost.
Designating authorities shall consult, as necessary, with the relevant regulatory authorities of the other Party to ensure that all regulatory requirements are identified and are satisfactorily addressed.
SECTORAL ANNEX ON MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION TO THE EUROPEAN COMMUNITY-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in New Zealand and the European Community, and to which Good Manufacturing Practice (GMP) requirements apply.
For medicinal products covered by this Sectoral Annex, each Party willll recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations or licences granted by the competent authorities of the other Party.
In addition, the manufacturer's certification of the conformity of each batch to its specifications will be recognised by the other Party without re-control at import.
‘Medicinal products’ means all products regulated by the pharmaceutical legislation in the European Community and New Zealand as listed in the Appendix to this Annex. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs, and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.
‘GMP’ is that part of quality assurance which ensures that products are consistently produced and controlled during manufacture to the quality standards appropriate to their intended use and as required by the marketing authorisation granted by the importing Party. For the purpose of this Sectoral Annex it includes the system whereby the manufacturer receives the specification of the product and/or process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification (Equivalent to Qualified Person certification in the European Community).
With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request that, for the purpose of this Agreement, an inspection be made by the locally competent inspection service. This provision will apply
to the manufacture of active pharmaceutical ingredients and intermediate products and products intended for use in clinical trials, as well as agreed pre-marketing inspections. Operational arrangements are detailed under Section III, item 3b.
Certification of manufacturers
At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision manufacturers of medicinal products will certify that the manufacturer:
— is appropriately authorised to manufacture the relevant medicinal product or to carry out the relevant specified manufacturing operation,
— is regularly inspected by the authorities, and
— complies with the national GMP requirements recognised as equivalent by the two Parties, and which are listed in Appendix 1 to this Sectoral Annex. In case different GMP requirements are used as a reference (in line with the provisions in Section III, item 3(b), this is to be mentioned in the certificate.
The certificates will also identify the site(s) of manufacture (and contract testing laboratories, if any). The format of certificate is attached as Appendix 2; it may be modified by the Joint Committee, as established in Article 12 of the Agreement.
Certificates will be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, such as when a new inspection has to be carried out, this period may be extended to 60 days.
Each batch exported will be accompanied by a batch certificate prepared by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate will attest that the batch meets its specifications and will be kept by the importer of the batch. It will be made available upon request of the competent authority.
When issuing a certificate, the manufacturer will take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It will contain a statement that the batch processing and packaging records were reviewed and found to be in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Community the ‘qualified person’ referred to in Article 21 of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. In New Zealand, the responsible persons are:
— for pharmaceuticals for human use: the authorised person responsible for Quality Assurance named on the licence to manufacture (Medicines Act 1981); and
for animal remedies (veterinary medicines): the authorised person responsible for Quality Assurance named on the manufacturers licence (Agricultural Compounds and Veterinary Medicines Act 1997).
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE REQUIREMENTS
Subject to Section III ‘Operational provisions’, general GMP inspections will be carried out in accordance with the GMP requirements of the exporting Party. The legislative, regulatory and administrative requirements are listed in Appendix 1.
However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, will be those of the relevant product marketing authorisation granted by the importing Party.
Transmission of inspection reports
Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing site or control site, in the case where analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see item 2 below). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin.
If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 days should a new inspection be carried out.
A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party.
(a) Manufacturers will be inspected in accordance with the applicable GMP of the exporting country (see Appendix 1);
(b) With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations will inspect in accordance with its own GMP or, in the absence of specific GMP requirements, in accordance with the applicable GMP of the importing country. This will also be the case when the locally applicable GMP are not considered equivalent, in terms of quality assurance of the finished product, to the GMP of the importing Party.
Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) will be determined according to a procedure established by the Joint Committee.
(a) Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections);
(b) ‘Product- or process-oriented’ inspections (which may be ‘pre-marketing’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.
Inspection/establishment fees
The regime of inspection/establishment fees is determined by the manufacturer's location. Inspection/establishment fees will not be charged to manufacturers located on the territory of the other Party for products covered by this Agreement, except as provided for in paragraph 6 below.
Safeguard clause for inspections
Each Party reserves the right to conduct its own inspection for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the option of joining the inspection. Recourse to this safeguard clause should be an exception. Should such an inspection take place, inspection costs may be recovered.
Exchange of information between authorities and approximation of quality requirements
In accordance with the general provisions of the Agreement, the Parties will exchange any information necessary for the mutual recognition of inspections.
In addition, the relevant authorities in New Zealand and in the European Community will keep each other informed of any new technical guidance or inspection procedure. Each Party will consult the other before their adoption and will endeavour to proceed towards their approximation.
The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement does not encompass mutual recognition of official batch releases. However, when an official batch release procedure applies, the manufacturer will provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party.
For the European Community, the official batch release procedure for medicinal products for human use is specified in document ‘Administrative EC Batch Release Procedure III/3859/92’ and different specific batch release procedures. For New Zealand, the official batch release procedure is specified in document ‘WHO Technical Report Series, No 822, 1992’.
In accordance with the general provisions of the Agreement, training sessions for inspectors, organised by the authorities, will be accessible to inspectors of the other Party. The Parties to the Agreement will keep each other informed on these sessions.
In accordance with the general provisions of the Agreement, and by mutual agreement between the Parties, joint inspections may be authorised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form shall be agreed through procedures approved by the Joint Committee.
Contact points will be agreed between the Parties to permit competent authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure will be agreed.
The Parties will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, are communicated to each other with the appropriate degree of urgency.
For the purpose of this Agreement, the contact points for any technical question, such as exchange of inspection reports, inspectors training sessions, technical requirements, will be:
Both Parties will use their best endeavours to resolve any divergence of views concerning
compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Joint Committee.
TRANSITIONAL ARRANGEMENTS FOR VETERINARY MEDICINAL PRODUCTS
In respect of veterinary medicinal products, the European Community will, subject to satisfactory verification of New Zealand's GMP inspection programme, recognise the conclusions of New Zealand GMP inspections and of New Zealand manufacturers' certifications of batch conformity, three years after the entry into force of the Agreement. New Zealand will, subject to satisfactory verification of the European Community's GMP inspection programme, recognise the conclusions of the European Community's inspections and of the European Community's manufacturers' certifications of batch conformity three years after the entry into force of the Agreement. During this three-year period, joint inspections, carried out in accordance with Section III, item 10, of this Sectoral Annex, may be authorised as a means to build further confidence between the Parties regarding the application and interpretation of their respective requirements.
The terms of any existing recognition arrangements concerning imports into New Zealand will remain valid during this three-year period.
List of applicable legislative, regulatory and administrative provisions
For the European Community:
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as extended, widened and amended
Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as extended, widened and amended
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products
Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use
Guide to Good Distribution Practice (94/C 63/03)
Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV
Medicines Regulations 1984
New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Parts 1, 2, 4 and 5
Agricultural Compounds and Veterinary Medicines Act 1997
Animal Remedies Regulations 1980
Code of GMP for Animal Remedies 1994
Medical devices incorporating medicinal substances
In order to meet European Community requirements, the following procedures will apply to medical devices incorporating medicinal substances referred to in Article 1(4) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices:
(a) if a medical device incorporates a substance which is already established by monographs of the European Pharmacopoeia, the consultation required under Annex II or III of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices will be carried out with the Therapeutics Section of the New Zealand Ministry of Health;
(b) if a medical device contains a substance other than one specified in the European Pharmacopoeia, the Ministry of Health will carry out such consultation with one of the competent authorities within the European Community responsible for authorising the placing on the market of medicinal products.
The Parties note New Zealand's intention to introduce new legislation concerning medical devices and agree that the provisions of this Sectoral Annex will apply to this legislation upon its entry into force in New Zealand.
Where required by New Zealand legislative, regulatory and administrative provisions, European Community conformity assessment bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with clause 2 in Section IV of this Sectoral Annex.
Recording of approvals granted
In addition to the requirements imposed by the Annex to the Agreement, on designation of a conformity assessment body, the relevant European Community designating authority will provide to New Zealand, in respect of each designated conformity assessment body, details of the method that that conformity assessment body intends to adopt to record the fact that an approval within the meaning of Regulation 90 of the Electricity Regulations 1997 has been granted.
Both parties will use their best endeavours to resolve any divergence of views concerning compliance of manufacturers and conclusions of conformity assessment reports. Unresolved divergencies of view will be referred to the Joint Committee.
SECTORAL ANNEX ON TELECOMMUNICATIONS TERMINAL EQUIPMENT TO THE EUROPEAN COMMUNITY-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
The Parties note that under the Telecommunications Act 1987, no person can connect any additional line, apparatus or equipment to any part of a network, or connect to any line, apparatus or equipment connected to any part of a network owned by a network operator, without the agreement of that network operator. Under the Act, network operators have the right to specify conditions under which telecommunications terminal equipment may be connected to their network.
Telecommunications terminal equipment offered for sale for connection to the Telecom New Zealand Limited (‘Telecom’) network is required to bear a Telepermit label incorporating a Registered Telecom trade mark, prepared to the format specified by Telecom, also showing the brand and model of the product and the number allocated to that product. Telepermit labels may be attached by the manufacturer in the country of origin.
The manufacturer or New Zealand importer applies to Telecom for a Telepermit and the right to label conforming products, and contracts with Telecom to continue to supply only such product which complies with Telecom's requirements.
The Parties note that equipment suppliers are required to lodge with Telecom a copy of the certificate of compliance and supporting test reports when the product is placed on the market. Compliance with Telecom's requirements may be verified by Telecom through post-marketing surveillance.
Where required by New Zealand legislative, regulatory and administrative provisions, European Community Conformity Assessment Bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with clause 2 in Section IV of this Sectoral Annex.
In respect of telecommunications terminal equipment which is subject to the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, the relevant provisions of the Sectoral Annexes on, respectively, Low Voltage Equipment and Electromagnetic Compatibility will apply.
SECTORAL ANNEX ON LOW VOLTAGE EQUIPMENT TO THE EUROPEAN COMMUNITY-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITYASSESSMENT, CERTIFICATES AND MARKINGS
The provisions of this Sectoral Annex will apply to the following types of low voltage equipment:
Where required by New Zealand legislative, regulatory and administrative provisions, European Community Conformity Assessment Bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with clause 2 in Section IV of this Sectoral Annex.
In the event of a challenge within the European Community under Article 8(2) of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits, test reports issued by designated conformity assessment bodies in New Zealand will be accepted by authorities in the European Community in the same way that reports from European Community notified bodies are accepted. That is, conformity assessment bodies in New Zealand will be recognised under Article 11 of that Council Directive as ‘bodies which may make a report in accordance with Article 8’.
In addition to the requirements imposed by the Annex to the Agreement, on designation of a conformity assessment body, the relevant European Community designating authority will provide to New Zealand, in respect of each designated conformity assessment body, details of the method that that conformity assessment body intends to adopt to record the fact that an approval within the meaning of Regulation 90 of the Electricity Regulations 1997 has been granted.
SECTORAL ANNEX ON ELECTROMAGNETIC COMPATIBILITY TO THE EUROPEAN COMMUNITY-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
Where required by New Zealand legislative, regulatory and administrative provisions, European Community conformity assessment bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with clause 2 in Section IV of this Sectoral Annex.
In addition to the requirements imposed by the Annex to the Agreement, on designation of a conformity assessment body, the relevant European Community designating authority will provide to New Zealand, in respect of each designated conformity assessment body, details of the method that that conformity assessment body intends to adopt to record the fact that an approval within the meaning of Regulation 90 of the Electricity Regulations 1997 has been granted.
SECTORAL ANNEX ON MACHINERY TO THE EUROPEAN COMMUNITY-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
The provisions of this Sectoral Annex will apply to the following:
Where required by New Zealand legislative, regulatory and administrative provisions, European Community conformity assessment bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with clause 2 in Section IV of this Sectoral Annex.
In respect of machinery which is subject to the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, the relevant provisions of the Sectoral Annexes on, respectively, Low Voltage Equipment and Electromagnetic Compatibility will apply.
Upon the date of application of the provisions of the Directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery, at present European Commission proposal COM(95) 350, bodies in New Zealand which have been designated to issue type approvals according to this Directive will, either directly or through the authority responsible for their designation, fulfil the notification and other obligations placed upon approval authorities under the relevant provisions of this Directive.
It is noted further that this proposed Directive makes reference to the conformity assessment requirements set out in Council Directive 92/53/EEC of 18 June 1992 amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers. It is recognised that under the provisions of this Directive, a manufacturer cannot be accredited as a testing laboratory. However, it is permissible for a testing laboratory to use outside equipment, subject to the approval of the Designating Authority.
(1) The legislative, regulatory and administrative requirements of the European Community with which New Zealand designated conformity assessment bodies will assess compliance
SECTORAL ANNEX ON PRESSURE EQUIPMENT TO THE EUROPEAN COMMUNITY-NEW ZEALAND AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS
The provisions of this Sectoral Annex will apply to the following types of pressure equipment:
Where required by New Zealand legislative, regulatory and administrative provisions, European Community conformity assessment bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with clause 2 in Section IV of this Sectoral Annex.
In respect of pressure equipment which is subject to the provisions of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility, the relevant provisions of the Sectoral Annexes on, respectively, Low Voltage Equipment and Electromagnetic Compatibility will apply.
In addition to the requirements imposed by the Annex to the Agreement, on designation of a conformity assessment body, the relevant designating authority will provide to New Zealand, in respect of each designated conformity assessment body, details of whether the conformity assessment body is carrying out design verification, or product inspection, or both.
(1) These regulations have yet to be incorporated into the law of New Zealand.
The plenipotentiaries of:
the EUROPEAN COMMUNITY, hereinafter referred to as ‘the Community’,
the plenipotentiary of NEW ZEALAND,
meeting for the signature of the Agreement on Mutual Recognition in relation to Conformity Assessment between the European Community and New Zealand, hereinafter referred to as the ‘Agreement’, have adopted the following texts:
the Agreement including its Annex and the following Sectoral Annexes relating to:
Medicinal Products GMP Inspection and Batch Certification
Telecommunications Terminal Equipment
Electromagnetic Compatibility
The plenipotentiaries of the Community and the plenipotentiary of New Zealand have adopted the texts of the Joint Declarations listed below and annexed to this Final Act:
— Joint Declaration relating to future work on implementing arrangements for this Agreement,
— Joint Declaration on mutual recognition in the voluntary sphere,
— Joint Declaration relating to further developing harmonisation of technical regulations and conformity assessment procedures,
— Joint Declaration relating to the review of Article 4 of the Agreement.
Hecho en Wellington, el veinticinco de junio de mil novecientos noventa y ocho.
Udfærdiget i Wellington den femogtyvende juni nitten hundrede og otteoghalvfems.
Geschehen zu Wellington am fünfundzwanzigsten Juni neunzehnhundertachtundneunzig.
Έγινε στο Ουέλλιγκτον, στις είκοσι πέντε Ιουνίου χίλια εννιακόσια ενενήντα οκτώ.
Done at Wellington on the twenty-fifth day of June in the year one thousand nine hundred and ninety-eight.
Fait à Wellington, le vingt-cinq juin mil neuf cent quatre-vingt-dix-huit.
Fatto a Wellington, addì venticinque giugno millenovecentonovantotto.
Gedaan te Wellington, de vijfentwintigste juni negentienhonderd achtennegentig.
Feito em Wellington, em vinte e cinco de Junho de mil novecentos e noventa e oito.
Tehty Wellingtonissa kahdentenakymmenentenäviidentenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.
Som skedde i Wellington den tjugofemte juni nittonhundranittioåtta.
For Det Europæiske Fællesskab
Für die Europäische Gemeinschaft
Για την Ευρωπαϊκή Κοινότητα
For the European Community
Pour la Communauté européenne
Voor de Europese Gemeenschap
Euroopan yhteisön puolesta
På Europeiska gemenskapens vägnar
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Joint Declaration relating to future work on implementing arrangements for this Agreement
The Parties will extend the scope of the Sectoral Annex on Pressure Equipment and start negotiations to that effect once the new Directive on this subject, at present being examined in the Council of the European Union and the European Parliament on the basis of a European Commission proposal, has entered into force.
Aircraft certification and continued airworthiness
The Parties confirm their intention to continue negotiations in order to complete the Sectoral Annex in respect of aircraft certification and continued airworthiness, with a view to its establishment as an implementing arrangement for this Agreement no later than two years following its entry into force.
Inclusion of other Sectoral Annexes
To build on this Agreement, the Parties will commence negotiations on the further extension of the sectoral coverage of the Agreement two years from the date that the Agreement enters into force.
Joint Declaration on mutual recognition in the voluntary sphere
The Parties will encourage their non-governmental bodies to cooperate with a view to establishing mutual recognition arrangements in the voluntary sphere.
Joint Declaration relating to further developing harmonisation of technical regulations and conformity assessment procedures
The Parties will give consideration to increasing the degree of harmonisation or equivalence of their respective technical regulations and conformity assessment procedures, where appropriate and where consistent with good regulatory practice. The Parties acknowledge that one objective could be the establishment where feasible of a single submission and evaluation procedure, applicable in both Parties, for the products covered by the Agreement.
Joint Declaration relating to the review of Article 4 of the Agreement
The Parties will consider a broadening of the provisions of Article 4 to include other countries once the Parties have concluded equivalent Agreements on Mutual Recognition in relation to conformity assessment in the same sectors with those other countries.
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