Convention For The Mutual Recognition Of Inspections In Respect Of The Manufacture Of Pharmaceutical Products

Filename: 1970-InspectionsPharmaceuticalProducts.EN.txt
Source: UNTS 956:3; Sand

Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products

Source: Unofficial Text

PREAMBLE

The Republic of Austria, the Kingdom of Denmark, the Republic of Finland, the Republic of Iceland, the Principality of Liechtenstein, the Kingdom of Norway, the Portuguese Republic, the Kingdom of Sweden, the Swiss Confederation and the United Kingdom of Great Britain and Northern Ireland:

CONSIDERING that in the interest of public health pharmaceutical products whether exported or not should be produced according to appropriate standards;

CONSIDERING that the rapid development of new drugs, especially complex synthetic substances of great pharmacological potency, necessitates strict quality control of their manufacture;

CONSIDERING that official inspection is necessary to ensure such manufacturing control;

DETERMINED to have effective systems of national inspection and testing of pharmaceutical products operating in their countries;

HAVING regard to the work already undertaken between the Nordic countries and to the discussions in progress in other international organizations, especially the World Health Organization and the Council of Europe (Partial Agreement);

CONSIDERING that the present Convention would contribute towards the removal of obstacles in international trade on a wider scale through the recognition of inspections made by national health authorities;

HAVE AGREED as follows:

PART I

Exchange of information

Article 1

1. The Contracting States shall exchange, in accordance with the provisions of this Convention, such information as is necessary for the mutual recognition of inspections relating to pharmaceutical products manufactured within their territories and intended for import into other Contracting States.

2. For the purpose of this Convention "pharmaceutical product" means:

(a) any medicine or similar product intended for human use which is subject to control by health legislation in the manufacturing Contracting State or in the importing Contracting State; and

(b) any ingredient which the manufacturer uses in the manufacture of a product referred to in subparagraph (a) above.

Article 2

1. Upon the request of the competent authority of a Contracting State into which a pharmaceutical product manufactured in another Contracting State is to be imported, the competent authority of the latter State shall, subject to the provisions of Article 4, provide information regarding:

(a) the general standards of manufacturing practice in a particular firm;

(b) the specific standards of manufacture and control of a given product in a particular firm;

(c) supplementary questions of the requesting competent authority which are relevant to the quality control of pharmaceutical products and based on the legal provisions of the importing Contracting State.

2. Information provided under this Convention shall not extend to data concerning financial and commercial matters or, in so far as they are not related to quality control of manufacture, to data concerning technical "know-how", research information and personal data other than those relating to the duties of the persons concerned.

Article 3

1. The information to be provided shall be based on inspections carried out by the competent authority. Such inspections shall normally be those made in the course of the enforcement of the system of compulsory control established in the manufacturing Contracting State.

2. If the product concerned does not fall within the system of compulsory control established by the manufacturing Contracting State or if the system of compulsory control of the manufacturing Contracting State, though applicable to the product concerned, does not extend to the particular aspects with regard to which the information is sought, the exporting manufacturer may apply to the competent authority of the manufacturing Contracting State for an inspection to be made on a voluntary basis.

Article 4

1. Before providing information about any particular firm or any product manufactured by it, the competent authority of the manufacturing Contracting State shall notify the manufacturer.

2. The manufacturer may at any time withhold his consent to information relating to his firm or to any product manufactured by him being disclosed to the competent authority of another Contracting State. In such a case the withholding of consent shall be notified to the competent authority of the Contracting State concerned, which may:

(a) where the information withheld relates to the general standards of manufacturing practice in the particular firm, regard any product of the manufacturer;

(b) where the information withheld relates to a specific product only, regard that specific product;

as being a product in respect of which full information has not been provided in accordance with this Convention.

Article 5

If a competent authority discovers in the course of its inspection duties or otherwise particular circumstances which cause a pharmaceutical product to be of imminent and serious danger to the public, it shall immediately communicate its findings to the competent authorities of the other Contracting States.

PART II

Inspections

Article 6

1. Inspection within the meaning of this Convention shall cover personnel, premises and facilities, equipment, hygiene and manufacturing and control procedures. The essential factors to be covered are product quality specifications and production control. Product quality specifications may be found in official formularies or should be established by the manufacturer. Production control embodies:

(a) environmental control pertaining to suitability of premises, equipment and staff;

(b) manufacturing control with respect to process inherent factors which might adversely affect the execution of manufacturing procedures and with regard to adverse extraneous factors;

(c) final control of the finished products to ensure that they comply with the established specifications and have been manufactured and controlled according to prescribed procedures.

2. The Contracting States shall ensure:

(a) that their competent authority has the power to call for the submission of quality control records and, if appropriate, samples relating to any batch of any pharmaceutical product;

(b) that the inspectors in the service of their competent authorities have appropriate qualifications and experience for the task to be undertaken by them.

PART III

Mutual recognition of inspections

Article 7

The Contracting States accept and recognize as equivalent to their own national inspections in respect of the manufacture of pharmaceutical products those carried out in conformity with the provisions of this Convention by the competent authority of the manufacturing Contracting State, provided that full information is supplied in respect of the requirements in force in the importing Contracting State.

PART IV

Consultation

Article 8

1. Officials of the competent authorities shall meet whenever necessary but at least once a year in order to:

(a) make recommendations and proposals for standards of good manufacturing practice;

(b) exchange experience on means and methods of achieving appropriate and effective inspections;

(c) promote co-operation between the competent authorities to facilitate the application of the Convention;

(d) promote the mutual training of inspectors; and

(e) make recommendations on any question relating to the implementation of this Convention or to make proposals for its amendment; such recommendations or proposals shall be transmitted to the depositary Government of this Convention.

2. In the exercise of these functions account shall be taken, where appropriate, of current developments and work in other international organizations.

PART V

General

Article 9

1. This Convention shall be ratified by the signatory States. The instruments of ratification shall be deposited with the Government of Sweden which shall notify all other signatory States.

2. This Convention shall enter into force ninety days after deposit of the fifth instrument of ratification.In relation to any other signatory depositing subsequently this Convention shall enter into force thirty days after the date of deposit of the instrument of ratification but not before the expiry of the period of ninety days.

3. Any arrangements in relation to the inspection system of a Contracting State which are necessary in order to comply with the provisions of this Convention shall be completed not later than eighteen months after deposit of the instrument of ratification of that Contracting State. Such arrangements shall be communicated to the depositary Government which shall notify all other Contracting States.

4. Each Contracting State shall communicate to the depositary Government, which shall notify all other Contracting States, the name and address of its principal national authority which will be its competent authority within the meaning of this Convention.

Article 10

1. The depositary Government shall notify to all other Contracting States any recommendation relating to the implementation of this Convention received in accordance with paragraph 1(e) of Article 8.

2. The depositary Government shall submit to all other Contracting States for acceptance any proposal for amendment of this Convention received in accordance with paragraph 1(e) of Article 8 or from any Contracting State.

3. If, within sixty days from the date of the submission of a proposal for amendment, a Contracting State requests that negotiations be opened on the proposal, the depositary Government shall arrange for such negotiations to be held.

4. Provided it is accepted by all Contracting States, an amendment of this Convention shall enter into force thirty days after deposit of the last instrument of acceptance unless another date is provided for in the amendment. Instruments of acceptance shall be deposited with the depositary Government which shall notify all other Contracting States.

Article 11

1. Any State being a Member of the United Nations or of any of the specialized agencies or of the International Atomic Energy Agency or a party to the Statute of the International Court of Justice and having the national arrangements necessary to apply an inspection system comparable to that referred to in this Convention may, upon invitation of the Contracting States to be transmitted by the depositary Government, accede to this Convention.

2. The date of the entry into force of this Convention in relation to an acceding State shall be agreed between that State and the Contracting States.

3. Instruments of accession shall be deposited with the depositary Government which shall notify all other Contracting States.

Article 12

Any Contracting State may withdraw from this Convention provided that it gives twelve months' notice in writing to the depositary Government which shall notify all other Contracting States.

Article 13

The Explanatory Notes annexed to this Convention shall form an integral part of it and serve for the interpretation and explanation of its provisions.

IN WITNESS WHEREOF the undersigned, duly authorized thereto, have signed the present Convention.

DONE at Geneva this 8th day of October 1970 in a single copy in the English and French languages, both texts being equally authentic, which shall be deposited with the Government of Sweden by which certified copies shall be transmitted to all other signatory and acceding States.