Article 54 of Law 25/1990 of 20 December 1990 on the medicinal product includes, within the category of special medicinal products for homeopathic products, establishing that article, which the homeopathic products prepared industrially marketed with therapeutic indication will be subject to all the effects on the regime of medicinal products provided for in the Law, while its additional fourth provision provides that the preparation and marketing of the products homoeopathic without therapeutic indication shall be regulated by its specific regulation.

With regard to these medicinal products, the European Union has adopted Council Directive 92/73/EEC extending the scope of Directives 65 /65/EEC and 75 /319/EEC on the approximation of the laws of the Member States relating to: legal, regulatory and administrative provisions on medicinal products and for which complementary provisions are adopted for homeopathic medicinal products, which is incorporated into the national legal order by means of this Royal Decree.

On the other hand, according to the criteria laid down in Article 94 of Law 25/1990 of 20 December 1990, of the Medication, it is not justified that homeopathic medicinal products are financed by Social Security or State funds affected by health, within the National Health System.

This Royal Decree is dictated by the powers conferred on the State by Articles 149.1.1., 16. and 17. of the Constitution and 2.1 of Law 25/1990 of 20 December of the Medication, for the part, lays down the requirements necessary to ensure that the criteria of quality, safety and, where appropriate, the effectiveness of the authorisation, production and control of these medicinal products are observed, all of which constitutes legislation on products In the case of pharmaceutical products, it is also determined that homeopathic medicinal products are not included in the Social security pharmaceutical industry.

By virtue of the above, on a proposal from the Minister for Health and Consumer Affairs, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 11 November 1994,

D I S P O N G O:

CHAPTER I

General provisions

Article 1. Definitions.

1. For the purposes of this Royal Decree, a homeopathic medicinal product shall mean any medicinal product obtained from products, substances or compounds called homeopathic strains, in accordance with a homeopathic manufacturing process described in the Spanish Royal Pharmacopoeia, in the European Pharmacopoeia or in its defect, in a pharmacopoeia used officially in a country of the European Union.

All active components present in a homeopathic medicinal product will appear in homeopathic dilutions.

2. A homeopathic medicinal product may also contain several principles.

Article 2. Scope.

1. The provisions of this Royal Decree will apply to:

a) homeopathic medicinal products for human use with approved therapeutic indication.

b) Homeopathic medicinal products for human use without approved therapeutic indication.

2. These medicinal products must clearly indicate on their labelling their homeopathic nature in clear and legible characters, at least in the official language of the State.

3. It shall apply to homeopathic medicinal products covered by this Royal Decree, as provided for in Law 25/1990 of 20 December of the Medication, as regards the obligation of supply and supply.

4. Homeopathic medicinal products which are developed as a master formula or an official preparation are excluded from the scope of this Royal Decree.

5. Products classified as homeopathic intended for human use may not be placed on the market if they do not comply with the provisions of this Royal Decree.

CHAPTER II

Health authorization for homeopathic medicinal products for human use

Article 3. Character of the authorisation.

The authorization of homeopathic medicinal products for human use is a precondition for their marketing. It shall be awarded by the Directorate-General for Pharmacy and Health Products, which shall take due account of the records or authorizations already issued by another Member State.

Article 4. Authorisation of homeopathic medicinal products with approved therapeutic indication.

1. For the authorization of homeopathic medicinal products with approved therapeutic indication, the procedure laid down in Royal Decree 767/1993 of 21 May, governing the evaluation, authorization, registration and conditions of the dispensing of proprietary medicinal products and other industrially manufactured medicinal products.

2. The assessment of the pharmacological, toxicological and clinical trials of the medicinal products submitted for registration shall be made taking into account their homeopathic nature.

Article 5. Authorisation of homeopathic medicinal products without approved therapeutic indication.

1. For the authorisation of homeopathic medicinal products without approved therapeutic indication, the registration procedure laid down in this Article shall be followed provided that they meet all the following conditions:

a) That your route of administration be oral or external.

(b) Absence of particular therapeutic indication on the label or any information relating to the medicinal product.

c) That the degree of dilution ensures the safety of the medicinal product; in particular, the preparation must not contain more than one part per 10,000 of the mother tincture and not more than one hundredth of the lowest dose which may be The use of active substances in allopathic medicine whose presence in an allopathic medicinal product involves the obligation to present a prescription.

The conditions for dispensing these medicines will be established at the time of their authorization.

2. In the application for registration of homeopathic medicinal products referred to in this Article, preparations obtained from the same homeopathic strain or strains may be included.

The application for registration shall be accompanied by the relevant documentation to demonstrate, in particular, the pharmaceutical quality and the homogeneity and consistency of the manufacturing lots.

3. This documentation must contain the following data:

(a) Scientific name or other designation recognised in a pharmacopoeia of those referred to in Article 1.1 of the homeopathic strain or strains.

b) Management path, pharmaceutical forms, and degree of dilution to be recorded.

c) A description of the production and control of the homeopathic strain or strains.

d) Justification of his homeopathic character, based on an appropriate bibliography.

e) Description of the manufacturing and control procedure for each pharmaceutical form, as well as the dilution and dynamization methods used.

(f) Authorisation to manufacture the medicinal products to be registered in accordance with Article 7.

g) A copy of the supporting documentation of the authorisations obtained, where appropriate, for the same medicinal products in one or more countries of the European Union.

(h) One or more samples or models of the sales model to the public of the medicinal products to be registered.

i) Information on the stability of the medicinal product.

4. The labelling and, where appropriate, the package leaflet must include, in addition to the indication "homeopathic medicinal product", the following particulars:

a) Scientific name of the strain or strains, followed by the degree of dilution, using the symbols of the pharmacopoeia used.

(b) Name and address of the holder of the health authorisation and, where applicable, the manufacturer.

c) Form and route of administration.

d) The expiration date in clear form (month and year).

e) Gallic form.

f) Contents of the sales package.

g) Storage conditions, if applicable.

h) Special warnings if the medicine so requires.

i) Number of the manufacturing batch.

j) Health record number.

k) Price.

l) homeopathic medicinal product "without approved therapeutic indications".

m) A warning to advise the user to consult a doctor if symptoms persist during the use of the medication.

The texts will be presented, at least, in the official Spanish language of the State.

5. For the assessment of the documentation submitted in the application for registration of these homeopathic medicinal products, the general criteria shall apply and the administrative procedure laid down in Royal Decree 767/1993 of 21 May 1993 shall be followed. except those that relate to the demonstration of therapeutic efficacy.

6. Homeopathic medicinal products which do not meet the conditions laid down in point 1 of this Article shall be considered for the purposes of registration and authorization as homeopathic medicinal products for human use with approved therapeutic indications. shall comply with the provisions of Article 4.

CHAPTER III

Manufacturing, control and inspection

Article 6. Manufacturers of homeopathic medicinal products for human use.

The manufacturers of homeopathic medicinal products, will have the consideration of pharmaceutical laboratories and will be subject to all effects to the provisions established by Royal Decree 1564/1992, of December 18, by the that the system of authorization of pharmaceutical laboratories and importers of medicinal products and the guarantee of quality in their industrial manufacture is developed and regulated.

Article 7. Manufacturers and control. Quality assurance.

In the industrial manufacturing and control of homeopathic medicines, the same criteria will be applied as in the industrial manufacturing and control of medicines established in Royal Decree 1564/1992, of December 18, by that the system of authorization of pharmaceutical laboratories and importers of medicinal products and the guarantee of quality in their industrial manufacture and in the Royal Decree 767/1993, of 21 May, for which the assessment, authorisation, registration and authorisation conditions for proprietary medicinal products and other medicinal products for human use manufactured industrially, adapted to their homeopathic nature. This adaptation to the homeopathic nature will require compliance with the correct manufacturing and pharmaceutical production standards applicable to homeopathic medicinal products.

CHAPTER IV

Advertising

Article 8. Advertising of homeopathic medicinal products.

1. The advertising of homeopathic medicinal products shall be subject to the provisions of Royal Decree 1516/1994 of 25 June 1994 regulating the advertising of medicinal products for human use.

2. Homeopathic medicinal products with approved therapeutic indications may only be the subject of advertising intended for the public when they satisfy the conditions laid down for proprietary medicinal products.

3. In the advertising of homeopathic medicinal products without approved therapeutic indication, only the information contained in Article 5.4 of this Royal Decree may be used.

CHAPTER V

Foreign trade

Article 9. Import.

Only homeopathic medicinal products for human use that are authorized by the General Directorate of Pharmacy and Health Products may be imported.

Article 10. Export.

homeopathic medicinal products authorized by the General Directorate of Pharmacy and Health Products may be exported without any other requirement than prior communication of the export to the General Directorate.

CHAPTER VI

Cooperation with the Member States of the European Union and the European Economic Area

Article 11. Transmission of information.

1. Any health authority of a Member State of the European Union and of the European Economic Area may request information, in written form, from the Directorate-General for Pharmacy and Health Products on homeopathic medicinal products. manufactured in Spain.

2. Similarly, the Directorate-General for Pharmacy and Health Products may, at the request of the Autonomous Communities, request information from the health authorities of another Member State of the European Union and the European Economic Area. on homeopathic medicinal products manufactured in that State, by means of a reasoned letter.

3. The information transmitted shall relate to specific aspects relating to the quality and safety of homeopathic medicinal products.

Additional disposition first. Authorisation.

As of the entry into force of this Royal Decree, homeopathic medicines will require the corresponding authorization of the Ministry of Health and Consumer Affairs.

Additional provision second. Effects of the lack of express resolution.

After the corresponding maximum period for resolving the procedure without any express resolution, the application shall be deemed to be dismissed.

Additional provision third. Character of the rule.

This Royal Decree is adopted in the development of Law 25/1990 of 20 December of the Medicamento and has, except as provided in the fourth provision, the character of legislation of pharmaceutical products according to Article 149.1.16 of the Constitution, and in accordance with the provisions of article 2.1 of Law 25/1990 of 20 December 1990, of the Medication.

Additional provision fourth. Exclusion from the pharmaceutical provision of social security. Basic character.

Homeopathic medicines are excluded from funding from Social Security funds or state funds affected by health, in accordance with the provisions of Article 94 of Law 25/1990 of 20 December 1990. of the Medication. This provision is of a basic nature in accordance with the provisions of Article 149.1.1. and 17. of the Constitution.

First transient disposition. Period of adequacy.

The manufacturers of homeopathic medicinal products which, at the entry into force of this Royal Decree, are authorised as pharmaceutical laboratories, will have a period of six months to adapt their operation to the They shall inform the General Directorate of Pharmacy and Health Products, requesting the appropriate inspection visit.

Second transient disposition. Homeopathic medicines available on the market.

However, as indicated in the first provision, homeopathic medicinal products which are available on the market for the entry into force of this Royal Decree may be provisionally maintained, provided that within six months of the entry into force of this Royal Decree, the Ministry of Health and Consumer Affairs is directed to the documentation of the application for authorization and registration.

Final disposition first. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to make the necessary provisions for the 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 16 November 1994.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

MARIA ANGELES AMADOR MILLAN