The health guarantees in the foreign trade of medicines are regulated in our legal order in Title V of Law 25/1990 of 20 December of the Medicamento. Article 81 (6) of that Title V provides that the holder of a proprietary medicinal product in Spain may not prevent its importation and marketing by third parties provided that it is entered on the Spanish market with the guarantees laid down in that Law with the adaptations to be determined.

The regulation in Spain of the intra-Community movement of medicinal products for human use, which is commonly known as 'parallel imports' by both the Community institutions and the other Member States, should (a) to be placed in the context of national legislation and Community legislation on the free movement of goods within the European Union, i.e. Articles 28 et seq. of the EC Treaty. In this respect, a medicinal product lawfully marketed in one Member State may be marketed in another Member State irrespective of the marketing authorisation holder. The important development of this commercial practice in recent years, as a result of the differences in the prices of medicinal products in the Member States of the European Union, makes its specific regulation necessary by means of the present standard.

This Royal Decree establishes the conditions which, in accordance with national law, must bring together both the medicinal products and the natural or legal persons who perform the marketing activity parallel to the referred to in Article 1. It also provides for the appropriate prior authorisation procedure for the activity.

This Royal Decree, which has the status of legislation on pharmaceutical products in accordance with the provisions of Article 149.1.16. of the Constitution and Article 2.1 of Law 25/1990 of 20 December of the Medication, develops Article 81 of the Law, finding its normative enablement in the final disposition of the Law.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, the sectors affected, after the approval of the Minister of Public Administration, according to the Council of State and after deliberation of the Council of Ministers at their meeting on 27 October 2000,

DISPONGO:

CHAPTER I

General provisions

Article 1. Scope of application.

1. This Royal Decree shall apply to the movement within the Community as regards the marketing and distribution in Spain of proprietary medicinal products authorised and registered in the Register of Proprietary Medicinal Products of the Agency. Spanish del Medicamento, from another or other Member States of the European Union. For the purposes of this Royal Decree, such activity shall be referred to as 'parallel marketing'.

2. The marketing in Spain of proprietary medicinal products authorised by the centralised procedure provided for in Council Regulation 2309 /93/EEC of 22 July establishing the Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing the European Agency for the Evaluation of Medicinal Products.

3. For the purposes of this Royal Decree, the natural or legal person who carries out the parallel marketing of the medicinal product shall be deemed to be 'parallel marketer' where it is different from the holder of the authorisation marketing of the medicinal product.

CHAPTER II

Requirements

Article 2. Requirements of the pharmaceutical specialty subject to parallel marketing.

1. The proprietary medicinal product must have the appropriate marketing authorization in the Member State of origin and must be duly authorized and registered in Spain in the Register of Proprietary Medicinal Products of the Spanish Medicines Agency.

2. The labelling and package leaflet of the medicinal product must comply with the provisions of Royal Decree 2236/1993 of 17 December 1993 on the labelling and package leaflet of medicinal products for human use.

3. In the packaging material, the lot number, name and address of the parallel marketer must also be entered in the external packaging material which has been the subject of parallel marketing by the and, if it is a pharmaceutical specialty financed by the National Health System, include the seal coupon.

4. Without prejudice to Article 3 (1), the activities carried out in the process of packaging modification, including labelling by means of self-adhesive labels, packaging and presentation for the sale of the Pharmaceutical specialty which is the subject of parallel marketing in accordance with the provisions of this Royal Decree, must be carried out by a pre-authorized establishment and in the terms laid down in Article 70 of Law 25/1990 of 20 December 1990. In December, the Court of Medicine, and Royal Decree 1564/1992 of 18 December 1992, develops and regulates the system of authorization of pharmaceutical laboratories and importers of medicinal products and the guarantee of quality in their industrial manufacture.

In no case, the above activities may directly or indirectly affect the original status of the medicinal product.

Article 3. Personal and material requirements of the parallel marketer.

1. In accordance with the provisions of Royal Decree 1564/1992 of 18 December 1992 establishing and regulating the system of authorization of pharmaceutical laboratories and importers of medicinal products and the guarantee of quality in their industrial manufacture, the parallel marketer must be authorised as a manufacturer to perform in the national territory all or any of the stages of conditioning, packaging and/or relabelling.

2. In the event that the parallel marketer does not carry out the manufacturing activities referred to in the previous paragraph in the national territory, it must have the authorisation provided for in Royal Decree 2259/1994 of 25 November 1994, which Pharmaceutical stores and wholesale distribution of medicinal products for human use and pharmaceutical products are regulated.

Article 4. Information requirements.

1. Prior to the placing on the market of the proprietary medicinal product by the parallel marketer, the latter shall notify the holder of the marketing authorization for the medicinal product in Spain of its intention to carry out such activity on the national territory, as well as making it easier for you, if requested, for a sample of the reconditioned product for the purpose of verifying that the presentation for sale does not impair the reputation of the brand.

2. For the purposes of the appropriate controls, the parallel marketer must be kept at the disposal of the health authorities, at least up to two years after the expiry date, the data relating to each batch of products concerned: Date, origin, batch number, quantity of units that integrate it and name and address of the provider and recipients. You must also notify the Spanish Medicines Agency of the cessation of your activity.

CHAPTER III

Authorization procedure

Article 5. Objectives of the authorization.

The assessment prior to the authorisation of the parallel marketing is intended to verify that the applicant has the appropriate personal and material resources to ensure the pharmaceutical quality, in relation to the with the stages of conditioning, packaging and relabelling, and the correct preservation and distribution of the medicinal products, as well as the fulfilment of the objective requirements relating to the medicinal product.

Article 6. Request for authorization.

1. The authorisation for the parallel marketing of proprietary medicinal products in Spain will be requested from the Spanish Medicines Agency.

2. The application must be accompanied by the following information and documents:

a) The name and address of the applicant.

(b) Name and registered office of the holder of the pharmaceutical specialty registered in Spain and, if different, that of the Member State of provenance and manufacturers, where appropriate.

(c) Name of the pharmaceutical specialty in Spain and in the Member State of provenance (international trade mark and name).

d) Quantitative and qualitative composition, pharmaceutical form, therapeutic indications and posology, contraindications and side effects, particular conditions of conservation, routes of administration and presentation of the Pharmaceutical specialty in the Member State of provenance.

e) Declaration stating that the proprietary medicinal product in parallel is identical in composition to that authorised in Spain or, if different, in which it is shown that the differences do not Health involvement.

(f) Number of the marketing authorisation for the medicinal product in the Member State of origin and the Member State of destination.

g) Two samples of the pharmaceutical specialty as it will be marketed in Spain.

(h) Copy of the authorization required in Article 3 (1) or, where applicable, paragraph 2 of that Article. Where Article 3 (2) applies, it shall also be accompanied by a copy of the authorisation as a manufacturer issued by the Member State in which it carries out the manufacturing activities.

i) Copy of the notification provided for in Article 4 (1) of this Standard.

(j) Statement that the original state of the product has not been directly or indirectly affected, as provided for in Article 2 (4).

k) Detailed justification for modifications to the labelling, package leaflet and packaging material.

l) Contact person in case of quality problems and defects in the batch released (name, full address, twenty-four-hour telephone, fax and e-mail).

Article 7. Resolution of the procedure.

1. Within the maximum period of forty-five days, from the time the application has entered its Register, the Spanish Medicines Agency shall issue a reasoned decision, authorizing and assigning new national code or denying the authorization. Such a decision shall be notified to the person concerned within the same time limit, with an indication of the resources, the body before which they must be submitted and the time limits for bringing them together.

2. If the application does not comply with the requirements laid down in Article 6, the person concerned shall be required to provide, within a period of 10 days, to remedy the misconduct or to accompany the required documents, with a warning that, if he does not do so, he shall be withdrawal of its request, after resolution in which that circumstance was declared, indicating the facts produced and the applicable rules.

The duration of the maximum period for resolving the procedure and the notification of the decision shall be suspended from the notification to the person concerned from the previous requirement until his effective compliance with this or, where applicable, the the period granted for that purpose, without prejudice to the provisions of the preceding paragraph.

3. Against the decision rejecting the authorization, which ends the administrative route, the Director of the Spanish Medicines Agency may be entitled to request the replacement of the authorization within a period of one month, in accordance with the provisions of the provided for in Article 116 of Law No 30/1992 of 26 November 1992, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, or the application of a judicial-administrative appeal to the Central Court of -Administrative dispute, within two months, to be counted from the day following the receipt of the notification, in accordance with the provisions of Law 29/1998 of 13 July, regulating the Administrative-Administrative Jurisdiction.

Article 8. Suspension or revocation of the authorization.

Without prejudice to the adoption of the measures provided for in Article 106 of Law 25/1990 of 20 December 1990, the Spanish Medicines Agency may suspend or revoke the authorization granted when they cease to to meet the required requirements or the obligations set out in this Royal Decree are not met, by means of a reasoned decision, subject to the instruction of the file, with an audience of the person concerned.

Article 9. Modifications to the authorization.

1. The parallel marketer shall notify the Spanish Medicines Agency of any modifications to be made to the labelling, package leaflet or packaging material of the medicinal product, either as a result of the amendments made to it by the Member State of origin, either as a result of the modifications authorised by the Spanish Medicines Agency in the pharmaceutical specialty authorised in Spain.

2. The notification shall be accompanied by a detailed justification of the necessary modifications, as well as two samples of the pharmaceutical specialty which is the subject of parallel marketing as it shall be marketed.

3. Amendments shall be deemed to have been accepted if the application has not been refused within 30 working days or additional documentation is not required.

Article 10. Term of validity.

The authorisation for the parallel marketing of proprietary medicinal products shall be valid for five years from the date of notification of the same. The application for renewal of the authorisation shall be submitted three months before the expiry of its validity. However, the first authorisation shall be valid only until the time of the five-year renewal of the marketing authorisation for the proprietary medicinal product authorised in Spain.

If the application for renewal is not submitted within the time limit, the authorization for parallel marketing shall be revoked, in accordance with Article 8, and the medicinal product shall be withdrawn from the market after the expiry of the validity of the authorisation.

Single additional disposition. Character of legislation.

This Royal Decree is adopted in the development of Law 25/1990 of 20 December of the Medicament and has the character of legislation of pharmaceutical products for the purposes provided for in Article 149.1.16. Constitution.

Single repeal provision. Regulatory repeal.

All provisions of equal or lower rank are repealed as set forth in this Royal Decree.

Final disposition first. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to make the necessary provisions for the correct application and development of this Royal Decree.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid to October 27, 2000.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

CELIA VILLALOBOS TALERO