Spain. Commercialisation of Healthcare

Regulatory overview

What is the regulatory framework for medical products?

Legislation

The main legislation governing medical products in Spain is the Royal Legislative Decree 1/2015, approving the revised text of the Law on Guarantees and Rational Use of Medicines and Medical Devices (Guarantees Law). The Guarantees Law was enacted in 2006 to replace the Spanish Medicines Act 25/1990 (Former Medicines Law). The Guarantees Law regulates in detail medicinal products for human and veterinary use and also sets out the general principles of the regulations applicable to medical devices.

The Guarantees Law regulates the:

• Main quality and safety requirements applicable to medicines (such as authorisation process, research and development, distribution, dispensation, traceability, prescription regime, pharmacovigilance, and so on).

• Inclusion of medicines in the system for their reimbursement with public funds.

• Price setting rules and other conditions for reimbursement.

The Guarantees Law has been amended several times since its enactment, notably during the recent financial crisis, to incorporate several cost-cutting and savings measures.

Concerning medicines in particular, several royal decrees have been enacted to provide more detailed rules relating to several aspects of the Guarantees Law (and the Former Medicines Law). These royal decrees include:

• Royal Decree 1416/1994 on the promotion of medicines for human use.

• Royal Decree 109/1995 on veterinary medicines.

• Royal Decree 223/2004 on clinical trials with medicines.

• Royal Decree 1344/2007 on pharmacovigilance of medicines for human use.

• Royal Decree 1345/2007 on the procedure for the authorisation, registration and supply conditions of industrially-manufactured medicinal products for human use.

• Royal Decree 1246/2008 on the procedure for the authorisation, registration and pharmacovigilance of industrially-manufactured veterinary medicines.

• Royal Decree 1015/2009 on the availability of medicines in special situations.

• Royal Decree 824/2010 on pharmaceutical laboratories, producers of active ingredients for pharmaceutical use, and the international trade of medicines and investigational medicines.

• Royal Decree 1718/2010 on medical prescriptions and dispensation orders.

• Royal Decree 782/2013 on the distribution of medicines for human use.

• Royal Decree 870/2013 on online distance selling of non-prescription human use medicines.

• Royal Decree 177/2014 governing the reference price and homogeneous groups system within the National Healthcare System and certain information systems concerning reimbursement and pricing of medicines and medical devices.

• Royal Decree 477/2014 on the authorisation of non-industrial advanced therapy medicines.

Most recently, an unofficial draft of a new royal decree on pricing and reimbursement of medicines was made public. It is expected that this new royal decree will be approved within the next few months.

Medical devices are basically governed by:

• Royal Decree 1591/2009 on medical devices.

• Royal Decree 1662/2000 on in vitro diagnosis devices.

• Royal Decree 1616/2009 on active implantable devices.

Food supplements are governed by Royal Decree 1487/2009 on food supplements.

Regulatory authorities

The Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS) is the main body responsible for all technical and quality aspects of medicines. Economic aspects (particularly pricing and reimbursement) are dealt with by the General Directorate for the Basic Portfolio of National Health System Services and Pharmacy (Dirección General de Cartera Básica de Servicios del Sistema Nacional de Salud y Farmacia) (DGCB). Both the AEMPS and the DGCB are part of the Ministry of Health.

Spain is divided into 17 autonomous regions that have broad powers in relation to health matters and are responsible for, among other matters, providing and funding public healthcare services. To ensure the equal treatment of all citizens throughout Spain, certain basic healthcare services must be guaranteed for all Spanish citizens, and the central authorities are responsible for deciding what these services are. The health authorities of the autonomous regions are also responsible for monitoring compliance with applicable regulations concerning the distribution, dispensation and advertising of medicines and medical devices.

Private parties

Industry associations, particularly the Spanish Pharmaceutical Companies Trade Association (Asociación Nacional Empresarial de la Industria Farmacéutica - Farmaindustria) and the Spanish Federation of the Healthcare Technology Industry (Federación Española de Empresas de Tecnología Sanitaria) (FENIN) are very active in Spain. They have played a particularly important role in approving codes of good practice for the promotion of medicines and medical devices, and other dealings with healthcare professionals.

Fedifar (Federación de Distribuidores Farmacéuticos) represents the interests of the wholesale sector. Pharmacists have regional professional associations (Colegios Oficiales de Farmacéuticos) that are grouped, at a national level, in the Council of Pharmacists Professional Associations (Consejo General de Colegios Oficiales de Farmacéuticos) (CGCOF).

What types of medical products are regulated?

The following main categories of products are regulated:

• Medicines for human use and for veterinary use.

• Industrially-manufactured medicines and pharmaceutical compounding.

• Special medicines including:

• vaccines;

• biological medicines;

• human origin medicines;

• advanced therapy medicines;

• radiopharmaceuticals;

• psychoactive medicines;

• homeopathic medicines;

• traditional plant medicines; and

• medicinal gas.

• Medical devices (including in vitro devices and active implantable devices).

Drugs

What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

To manufacture medicines in Spain, a specific authorisation from the Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS) is required. This includes an inspection of the manufacturing facilities.

Advertising

The main regulations governing the promotion of medicines in Spain are contained in the Guarantees Law and Royal Decree 1416/1994, which governs the advertising of medicines for human use (Royal Decree on Advertising). The Ministry of Health and the autonomous regions of Madrid and Catalonia (where most Spanish pharmaceutical companies are based) have approved guidelines on certain provisions of the Royal Decree on Advertising in relation to promotional activities. The Code of Good Practice for the Pharmaceutical Industry further interprets and elaborates on these rules.

The main requirements for advertising medicines under the current legal framework are as follows:

• Promotion must be compatible with the approved summary of product characteristics (SPC). This means that there can be no promotion of a medicine before it has obtained a marketing authorisation, and the promotion must strictly refer to the indications and properties contained in the SPC. The autonomous regions' guidelines and the Code of Good Practice regulate, for example, the use of certain terminology or phrases, how to reproduce bibliographic references in promotional materials, or how to manage the delivery of information that refers to indications or characteristics not contained in the SPC approved in Spain (off-label information) in international scientific meetings.

• The purpose of visits by medical sales representatives (sales calls) must be to provide objective and technical knowledge. Medical sales representatives must be given adequate training and have sufficient scientific knowledge to be able to provide information that is as precise and as complete as possible about the medicines that they are promoting.

• Essentially, promotional materials (including both published advertising and brochures given to healthcare professionals during visits by medical sales representatives) must be scientific, and must be notified to the regional authorities before their distribution, attaching an express declaration that they have been reviewed by the appropriate department of the pharmaceutical

• Only specific categories of medicines can be advertised to the public. See Question 8 regarding specific requirements for advertising medicines to patients.

Sale

Marketing authorisation. To be placed on the Spanish market, drugs must obtain a prior marketing authorisation from the AEMPS (or the European Medicines Agency (EMA)) and be registered with the AEMPS's medicines registry.

The AEMPS is in charge of granting national marketing authorisations for medicines in Spain and can do so under the national, mutual recognition or decentralised procedures.

The national authorisation procedure is regulated by Royal Decree 1345/2007 on the procedure for the authorisation, registration and conditions for dispensation of industrial human medicines (Royal Decree 1345/2007). The authorisation process requires the submission of a detailed application that covers all aspects of the medicine, the results of pre-clinical, clinical and pharmaceutical investigations, and relevant expert reports. The documentation is assessed by the AEMPS, which can request additional information. The assessment of the positive therapeutic effects of the medicinal product will be considered in relation to any risk related to the quality, safety and efficacy of the medicinal product for the patient's health or public health, under a benefit/risk balance approach. The AEMPS issues a reasoned evaluation report which, if unfavourable, is submitted to the applicant before the adoption of the decision.

In accordance with EU law, as implemented in Spain, the decision of the AEMPS must be issued within 210 calendar days following the submission of a valid application. This term can be extended for three months (or exceptionally six months) if additional documentation is requested from the applicant.

Placing on the market. The placing of a medicine on the market for the first time must be notified in advance to the authorities. In addition, before marketing a prescription medicine, the pharmaceutical company must have submitted it to the national health authorities for inclusion in the reimbursed medicines system.

Medicines cannot be advertised or sold before completion of the formalities above.

Special situations. Unauthorised medicines can be supplied in special situations under Royal Decree 1015/2009 on the availability of medicines in special situations. In particular, the AEMPS can authorise the prescription and use (and import, where necessary) of:

• Investigational medicines, for patients suffering from chronic, severely debilitating or life-threatening conditions that cannot be satisfactorily treated with authorised medicines (compassionate use).

• Medicines authorised in countries other than Spain, if there is no appropriate alternative medicine authorised in Spain, or in cases of shortages.

These authorisations can be granted on a named patient basis, or under a general protocol applicable to a category of patients.

Dispensation. The dispensation of medicines to patients is reserved by law to:

• Authorised retail pharmacies open to the public.

• Pharmacies in hospitals, health centres and primary healthcare facilities of the National Health Service.

Only professional pharmacists can own and operate pharmacies. Pharmacies must have an authorisation granted by the appropriate authority in the autonomous region where the pharmacy is located, which is issued according to a quota system based on geographic location and population.

For the purposes of dispensation, medicines can be divided into two main categories:

• Prescription medicines.

• Non-prescription medicines (over-the-counter drugs (OTCs)).

Only doctors, dental practitioners and chiropodists are authorised to prescribe medicines. Royal Decree 1718/2010 on medical prescription and dispensation orders provides that nurses can issue "dispensation orders" for certain prescription medicines, provided that they hold a specific accreditation. This requires further regulation that has yet to be passed.

Online sales. Royal Decree 870/2013 on the online sale of non-prescription medicines for human use to the public was the first piece of legislation to regulate this practice and imposes the following conditions:

• Only OTCs can be sold online.

• Only authorised pharmacies can sell medicines online. To do so, they must notify the regional health authorities that they intend to engage in online sales.

• No intermediaries can be involved in the sale.

• Sales must be made by a pharmacist from his/her pharmacy and only after appropriate advice has been given to the user.

• No gifts, discounts, bonuses or equivalent can be given as a means of promoting medicines on a website.

Are there different requirements for patented and generic drugs?

The Guarantees Law sets out simplified procedures for granting marketing authorisations for generic drugs. There is no obligation to provide the results of the required pre-clinical and clinical trials if it is proven that the medicinal product is a generic of a reference medicinal product that is or has been authorised for a minimum of eight years in any member state of the EU, or by the EU, even if the reference medicinal product is not authorised in Spain Under (Article 17.3, Guarantees Law).

However, generic drugs cannot be commercialised until ten years have passed since the date of the initial authorisation of the reference medicinal product, or 11 years if a new indication was approved during the first eight years.

A medicinal product is considered as a generic of a reference product if the following conditions are met:

• It has the same qualitative and quantitative composition of active ingredients.

• It has the same pharmaceutical form.

• Its bioequivalence with the reference medicinal product has been proved by bioavailability studies.

What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The Spanish Parliament and Central Government are responsible for regulating the manufacture, advertising and sale of drugs.

The Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS) and the regional health authorities are responsible for applying the legislation and regulations, and for monitoring their implementation.

Where applicable, those laws and regulations must follow the general guidelines established at EU level. In addition, the European authorities are exclusively responsible for regulating certain aspects (such as authorisations for advanced therapy medicines).

See also Question 1, Regulatory authorities.

For more information on the AEMPS see box: The regulatory authorities.

Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

Authorisations granted by the European Medicines Agency (EMA) under the centralised procedure provided in Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMA Regulation) are immediately effective in Spain.

Medicines authorised in other EU countries can be recognised in Spain under the mutual recognition procedure laid down in Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive), and further regulated in Royal Decree 1345/2007.

A simplified procedure also exists for medicines whose active principles' use is well established. The applicant for the marketing authorisation can replace the results of clinical trials and pre-clinical studies with appropriate scientific documentation if it proves that the medicinal product's active ingredients have been used extensively for at least ten years in the EU and are acknowledged as being effective and safe.

Is it possible to sell drugs to or buy drugs from other jurisdictions?

To import medicines from other jurisdictions, a specific authorisation from the Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS) is required. This authorisation is not required if the product originates from another EU country (intra-Community trade), in which case a distribution licence is sufficient.

In any case, to be placed on the Spanish market, the product must have obtained a valid marketing authorisation in Spain and fulfilled the other formalities referred to in Question 3, Sale.

These requirements do not apply to products that are to be exported. However, in certain cases, the AEMPS must be informed in advance of the intention to export, and can object to it if there is a risk to public health in Spain (for example, due to product shortages).

In addition, medicinal products can only be purchased by or sold to entities in possession of a distribution licence (or by the manufacturers themselves).

Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

The only medicines that can be advertised to consumers are those that:

• Are not included in the public reimbursement system.

• Are not subject to medical prescription and do not require diagnosis or follow-up by a doctor.

• Do not contain narcotic or psychotropic substances.

Consequently, pharmaceutical companies must ensure that promotional materials for medicines that can only be advertised to healthcare professionals are not made available to the public in general.

Advertising aimed at consumers cannot:

• Refer to recommendations from scientists, healthcare professionals or other persons that could encourage the consumption of medicines.

• Suggest certainty as to the medicine's effects, lack of side effects, or enhanced efficacy as opposed to other treatments.

• Suggest that the use of the medicine may improve health or boost sporting performance.

In addition, advertising addressed exclusively or primarily to children is not allowed.

Consumers cannot be given free samples.

Following a recent amendment to the Medicines Law, advertising to consumers is not subject to prior administrative authorisation.

Medical devices

What are the general requirements for a medical device to be manufactured, advertised and sold?

Manufacturing

Under Royal Decree 1591/2009 on medical devices (Medical Device Regulation), the manufacture, import (from non-EU countries), grouping or sterilisation of medical devices is subject to administrative authorisation from the Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS).

In Spain, manufacturing can encompass one or more of the following activities: assembling, packaging, processing, fully refurbishing and/or labelling one or more ready-made products and/or assigning them to their intended purpose as a device with a view to place them on the market under the manufacturer's name.

In line with EU Directives, only CE marked medical devices can be commercialised or put into service in Spain. CE marking can only be placed on products for which there is evidence that they comply with the essential requirements set out in applicable regulations and which follow the applicable evaluation procedures, which differ depending on the nature of the product. For these purposes, products are classified into four categories, according to the criteria set out in Annex IX of the Medical Device Regulation:

• Class I.

• Class IIa.

• Class IIb.

• Class III.

The evaluation procedures may involve certification by a "notified body". In Spain, the notified body is the AEMPS.

The following devices are exempted from CE marking requirements:

• Customised medical devices.

• Medical devices used in clinical investigation.

In any case, the manufacturer must follow specific evaluation procedures and issue a declaration of conformity.

Advertising

Under Article 38 of the Medical Devices Regulation, the advertising of devices is governed by:

• The general principles set out in the General Advertising Law.

• Articles 27 and 102 of the General Healthcare Law 14/1986.

• The Guarantees Law.

Advertising devices directly to the public requires prior authorisation from the health authorities (Article 102, General Healthcare Law; Article 8, General Advertising Law). Additional requirements are discussed in Question 12.

Distribution and sale

Any entity that places class III, class IIb or class IIa devices on the market or puts them into service in Spain for the first time must report this activity to the AEMPS. Any subsequent changes to the information that has been reported to the AEMPS (or the relevant regional authorities) must also be reported.

Any entity established in Spain that is responsible for the initial commercialisation of class I devices or custom-made devices in the EU must be registered with the AEMPS.

The regional health authorities monitor the distribution of medical devices and can carry out inspections to this end. To assist the authorities in these tasks, distributors of medical devices must file a notification with the relevant regional health authorities before commencing their activities. This notification must include:

• Details of their distribution and retail premises (located in the region).

• The type of products that are sold or distributed.

• The identity of the qualified professional in charge of the premises.

The provision of custom-made devices to the public is subject to prior authorisation of the health authorities.

What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The Spanish Parliament and Central Government are responsible for regulating the conditions for the manufacture, advertising and sale of devices, in line with the general requirements established at EU level.

The Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS) is the notified body responsible for assessing conformity of medical devices in Spain. It is also responsible for monitoring the initial placement of devices on the Spanish market.

The regional health authorities are responsible for supervising and monitoring distribution, sale and advertising activities.

For more information on the AEMPS see box: The regulatory authorities.

Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

Devices that already have CE marks according to the rules applicable in other EU countries benefit from a presumption of conformity in Spain.

However, if the Spanish health authorities consider that a device, used for its intended purpose, may compromise the health or safety of patients, they can take measures to withdraw it from the market or restrict its commercialisation under the safeguard clauses included in applicable EU directives.

Is it possible to sell devices to or buy devices from other jurisdictions?

Medical devices imported from other EU countries can freely circulate in Spain. However, they can only be placed on the Spanish market if they meet the requirements described in Question 9.

To import devices from non-EU countries, a specific authorisation from the Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS) is required. The products to be imported must bear the CE mark and have passed the relevant evaluation procedures.

Devices can also be manufactured exclusively for export to non-EU countries, in which case they do not need to fulfil the requirements set out in EU and Spanish law. However, they must be clearly identified as such and differentiated from those to be placed on the EU market.

Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

As a general rule, written, audiovisual or of any other type of promotional materials regarding medical devices must be primarily scientific in terms of content and be distributed to healthcare professionals (Article 38, Medical Devices Regulation). However, advertising to the public is permitted under certain conditions, subject to prior administrative authorisation if the advertising is to be used in mass media, including the internet.

Medical devices reimbursed by the National Health System cannot be advertised to the public. Premiums, gifts or discounts linked to the promotion or sale of devices cannot be offered to the public.

Medical devices intended to be used by healthcare professionals cannot be advertised to the public.

There are additional restrictions on specific devices. For example, self-diagnosis devices (except for pregnancy and fertility tests) and genetic diagnosis devices cannot be advertised to the public.

Biological products

What are the general requirements for a biological product to be manufactured, advertised and sold?

Under Spanish and EU law, a biological medicinal product is a product which active substance is a biological substance. Biological products include, among others:

• Immunological medicinal products.

• Medicinal products derived from human blood and human plasma.

• Advanced therapy medicinal products.

Under Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMA Regulation), certain biological products, such as advanced therapy products, can only be authorised by the European Medicines Agency (EMA) under the centralised procedure.

Except for this specific regime, biological medicines are generally subject to the same general requirements for manufacturing, advertising and sale as other medicines (see Question 3).

What authority is responsible for regulating the manufacture, advertising and sale of biological products?

The regulatory authorities are the same as for other medicines (see Question 5).

Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

The simplified procedure used for the approval of generic drugs (see Question 4) can be followed for a biological product that is similar to a previously authorised biological product (the reference product). However, where a biological medicinal product that is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products owing, in particular, to differences relating to raw materials or differences in manufacturing processes of the similar and the reference biological medicinal product, the results of pre-clinical tests or clinical trials relating to these conditions must be provided (Article 17.4, Guarantees Law).

Is it possible to sell biological products to or buy biological devices from other jurisdictions?

Biological medicines are subject to the same rules as other medicines (see Question 7).

Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

Biological medicines are subject to the same rules as other medicines (see Question 8). However, biological medicines must generally be prescribed by a healthcare professional and, therefore, cannot be advertised to consumers.

Natural health products

Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

There is no general category of "natural health products".

The Guarantees Law treats traditional herbal medicines and homeopathic medicines as categories of special medicines.

The basic rules on supplements, vitamins and minerals are set out by Spanish Royal Decree 1487/2009 on food supplements (Food Supplements Royal Decree), which implements Directive 2002/46/EC on food supplements (Food Supplements Directive). Food supplements are defined as foodstuffs the purpose of which is to supplement a normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, such as:

• Capsules, pastilles, tablets, pills and other similar forms.

• Sachets of powder.

• Ampoules of liquids.

• Drop dispensing bottles.

• Other similar forms of liquids and powders designed to be taken in measured small unit quantities.

To avoid the product being classified as a medicinal product, special attention must be paid both to claims made when marketing the product and to the composition of the product itself.

Under Spanish and EU regulations and the case law of the European Court of Justice (ECJ), a substance or combination of substances can be classified as a medicinal product on the grounds of its presentation or function. A product will not come within the definition of medicinal product by presentation if it is not marketed as being fit to prevent, treat or cure a disease, or include these types of statements in its packaging or advertising. However, depending on the product's composition, it may still come within the definition of medicinal product by function. The assessment must be based on the product's intended use and the actual effects of its specific content on the human body.

According to the ECJ's case law, in order to determine whether a product falls under the definition of medicinal product by function, the national authorities must decide on a case-by-case basis taking account of all the characteristics of the product, in particular:

• Its composition.

• Its pharmacological, immunological and/or metabolic properties, and the extent to which these can be established in the present state of scientific knowledge.

• The manner in which it is used.

• The extent of its distribution.

• Its familiarity to consumers.

• The risks which its use may entail.

Therefore, the key test is to determine whether the particular contents of each product lead to the conclusion that, used in a normal way, they affect the metabolism or modify bodily functions to an appreciable extent. This must be established by reference to scientific knowledge at any given time and on a product-by-product basis.

What are the general requirements for natural health products to be manufactured, advertised and sold?

Traditional herbal medicines and homeopathic medicines

Traditional herbal medicines and homeopathic medicines are generally subject to the same manufacturing, advertising and sale requirements as apply to medicines generally (see Question 3).

Traditional herbal medicines. Under Article 51 of the Guarantees Law, plants traditionally considered as medicinal plants can be freely sold to the public provided that they are offered with no reference to therapeutic, diagnostic or preventive properties. However, door-to-door sales are forbidden.

Herbal medicines are subject to essentially the same regulations as other medicines, with some particularities set out in Royal Decree 1345/2007. Herbal medicines are defined as plants and mixtures of plants, as well as preparations obtained from plants in the form of extracts, lyophilisations, distillates, tinctures, concentrations or any other pharmaceutical preparation presented with therapeutic, diagnostic or preventive properties.

Homeopathic medicines. Article 50 of the Guarantees Law defines homeopathic medicines as medicinal products obtained from homeopathic strains in accordance with a homeopathic manufacturing process described in the European Pharmacopoeia or in the Spanish Royal Pharmacopoeia or, failing that, in a pharmacopoeia officially used in an EU country. A homeopathic medicinal product can contain several active ingredients.

Under Royal Decree 1345/2007, homeopathic medicines are classified as:

• Homeopathic medicines with an approved therapeutic indication. In this case, they will be subject to the standard authorisation and registration process.

• Homeopathic medicines with no approved therapeutic indications. These medicines can follow a simplified authorisation and registration process, provided that:

• they are administered orally or externally;

• they do not refer to any specific indication, in their labelling or in any other information material; and

• their degree of dilution is sufficient to guarantee that the medicine is innocuous, and in any case does not exceed a concentration of 1/10,000.

Under the simplified procedure, the scientific evidence can be largely based on bibliographic references, and pre-clinical studies can, if justified, be omitted.

Food supplements

The basic regulations are set out in the Food Supplements Royal Decree, which establishes the following, among other aspects:

• Vitamins and minerals. Only vitamins and minerals listed in the annexes to the Food Supplements Royal Decree can be used as ingredients in food supplements. They are also subject to the purity criteria established in EU legislation applicable to foodstuffs generally, or, in the absence of such legislation, to those established in Spanish legislation or by international bodies, whichever is stricter.

• Other ingredients. There is no closed list of other ingredients that can (or cannot) be used as ingredients in food supplements. Reports of the Scientific Committee on Food (currently, the European Food Safety Authority) and of other international bodies of recognised scientific expertise are taken into account.

Food supplements must be registered with the General Health Registry for Food Businesses and Foodstuffs.

Manufacturers and distributors of food supplements must register with the General Health Registry for Food Businesses and Foodstuffs. If an operator involved in these activities does not have premises or an establishment in Spain, it must be registered if its corporate domicile is in Spain.

Registration is achieved by notification to the relevant authorities, and must be done before the start of activities.

In addition, before commercialisation in Spain, the health authorities must be notified that a product is going to be placed on the market by submitting a sample of the product's label. Any amendment to the label and the discontinuation of the marketing of a product must also be notified. This notification must be made by the manufacturer or the person responsible for commercialising the product, to the health authorities of the region where it is domiciled. If this person does not have a domicile in Spain, the notification must be made to the Spanish Food Safety and Nutrition Agency.

For information on advertising requirements see Question 23.

What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

Traditional herbal medicines and homeopathic medicines

Traditional herbal medicines and homeopathic medicines are subject to the same rules as apply to medicines generally (see Question 5).

Food supplements

The Spanish Consumption, Food Safety and Nutrition Agency is the Central Government body in charge of promoting food safety generally. The regional health authorities are in charge of monitoring compliance with food safety regulations.

For more information on the Spanish Consumption, Food Safety and Nutrition Agency see box: The regulatory authorities.

Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

Traditional herbal medicines and homeopathic medicines

Traditional herbal medicines and homeopathic medicines are subject to the same rules as apply to medicines generally (see Question 6).

Food supplements

If a food supplement is already legally marketed in another EU member state, in order to apply the mutual recognition principle, it must be demonstrated that the product is legally marketed in that member state. To that end, the following must be provided:

• A copy of the product label used in the EU country where it was first marketed.

• A copy of the notification sent to that country's authority, together with its subsequent acceptance.

This documentation must be provided in Spanish (or translated into Spanish).

Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

Traditional herbal medicines and homeopathic medicines

Traditional herbal medicines and homeopathic medicines are subject to the same rules as apply to medicines generally (see Question 7).

Food supplements

The importation of food supplements from non-EU countries is subject to the same requirements described in Question 20, Food supplements. Food supplements can be sold online like any other consumer product.

Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

Traditional herbal medicines and homeopathic medicines

Traditional herbal medicines and homeopathic medicines are subject to the same rules as apply to medicines generally (see Question 8).

Food supplements

Regulation (EC) 1924/2006 on nutrition and health claims made on foods (Nutrition and Health Claims Regulation) restricts the use of nutrition and health claims on the labelling, presentation and advertising of foodstuffs. A nutrition claim is any claim that states, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a particular nutrient or other substance. A health claim is defined as any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Whenever a nutrition or health claim is made, nutrition labelling is generally required under the Nutrition and Health Claims Regulation. Only nutrition claims listed in the annex to this regulation are admissible. Using a health claim is subject to authorisation under any of the procedures set out in the regulation.

At a domestic level, the Food Supplements Royal Decree provides that the labelling, presentation and advertising of food supplements cannot:

• Include any statement that states or suggests that a balanced, varied diet does not provide adequate quantities of nutrients in general.

• Attribute to food supplements the property of preventing, treating or curing a disease or refer to such properties at all.

In addition, under Royal Decree 1907/1996 on advertising and commercial promotion of products, activities or services with alleged health effects, it is generally prohibited to make claims:

• Suggesting specific slimming properties.

• Using endorsements or any kind of authorisations, homologations or tests by Spanish or foreign health authorities.

• Suggesting or affirming an increase in physical, mental, sport or sexual performance.

There are rules relating to the use of recommendations or endorsements in advertising. In particular, the Spanish Law on Food Safety and Nutrition prohibits the use of endorsements from associations, corporations, foundations and institutions related to health and nutrition unless they are non-profit organisations and the organisation undertakes in writing to devote the financial resources obtained from the collaboration to activities aimed at improving health through research, development and specialised publications on health and nutrition.

Reform

Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

There are currently no noteworthy plans to reform the rules on the development, manufacture, advertising and sale of medical products.

The regulatory authorities Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS)

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Principal responsibilities. The AEMPS is the national body responsible for guaranteeing quality, safety, efficacy, availability and information about medicines and medical devices. It is in charge of assessing and authorising human and veterinary medicines, authorising clinical trials, market surveillance, inspection and control, anti-counterfeit measures, and so on.

Spanish Consumption, Food Safety and Nutrition Agency (Agencia Española de Consumo, Seguridad Alimentaria y Nutrición) (AECOSAN)

W www.aecosan.msssi.gob.es

Principal responsibilities. The AECOSAN is the national body responsible for, among other matters, general planning and strategies to guarantee food safety.

Online resources

Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) (AEMPS)

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Description. Official website of the AEMPS, which is updated regularly. The website includes:

• Details and text of applicable laws and regulations, classified by topic (in Spanish).

• A database of all approved medicines, pharmaceutical companies and authorised wholesalers.

• Medicine assessment reports.

• Alerts.

• Safety notes.

• Information about regulatory processes.

Some information is also available in English.

Spanish Consumption, Food Safety and Nutrition Agency (Agencia Española de Consumo, Seguridad Alimentaria y Nutrición) (AECOSAN)

W www.aecosan.msssi.gob.es

Description. Official website of the AECOSAN, which is regularly updated. Includes details and text of applicable laws and regulations, classified by topic (in Spanish) and guidance addressed to food business operators, other authorities and consumers.

Spanish Official Gazette

W www.boe.es/diario_boe

Description. Official website of the Spanish Official Gazette. Updated daily. Includes the full text of all laws and regulations approved by the Parliament and the Central Government.