Standards and specifications: Pharmaceutical Industry

These must comply with the provisions of Royal Legislative Decree 1/2015 of 24 July 2015 approving the recast text of the Law on guarantees and rational use of medicines and healthcare products and the legislation implementing it.

You can also consult:

• Legislation on medicines for human use – Registration of medicines
• Legislation on veterinary medicines

See further information on: Product standards and requirements. Pharmaceutical industry

Conformity assessment in the European Union (EU).

It must be ensured that products comply with certain standards before they are placed on the EU market. This procedure is called a conformity assessment.

In the field of healthcare products, compliance with harmonised standards, references for which have been published in the Official Journal of the European Union (EU), is a means for manufacturers:

• To be able to demonstrate compliance with the essential requirements in the case of directives, and
• With the general safety and operational requirements in the case of regulations,
• As well as other legal requirements, such as those referring to quality and risk management, established in the regulation.

In addition, references in the regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicines and materials used in products as containers for medicines, provided that the references of these monographs have been published in the Official Journal of the EU.

The elaboration of harmonised standards is the result of the work of recognised European standardisation bodies such as CEN or CENELEC following a ‘mandate’ from the European Commission. The application of harmonised standards in the design and manufacture of goods ensures that they comply with the relevant EU regulations. This is what is known as ‘presumption of conformity’.

Standardisation at national level

At national level, standardisation is handled by the national standardisation bodies – AENOR in the case of Spain – which adopt and publish standards in each country, incorporate all European standards by means of identical national standards and withdraw any national standards that conflict with these.

Do the harmonised standards necessarily apply?

The use of harmonised standards is voluntary. Manufacturers are free to choose other technical solutions to demonstrate compliance with mandatory legal requirements.

If they choose not to use harmonised standards for assessment, manufacturers may demonstrate conformity through reference to other technical specifications (i.e. national standards, non-harmonised European and international standards or their own technical specifications). In that case, they must provide further details in the technical documentation explaining how each product complies with the legal requirements.

What do you do when there are no harmonised standards?

Where there are no harmonised standards, or where the relevant harmonised standards are insufficient, or where there is a need to address public health issues, the Commission is empowered to introduce common specifications. These are a set of technical or clinical requirements, different from a standard, which provide a means of meeting the legal obligations applicable to a product, process or system.

Medical devices must meet the essential requirements in the case of directives and the safety and performance requirements in the case of regulations which apply to them, taking account of their intended purpose.

Who is responsible for declaring product conformity?

The manufacturer is responsible for declaring that the product conforms with all requirements. They must draw up a technical dossier documenting product conformity and draw up and sign the EU declaration of conformity.

Which bodies perform the conformity assessment?

Depending on the product classification, conformity assessment requires the intervention of a notified body. The NANDO page shows the designated notified bodies for each directive and regulation.

If a notified body is required to intervene, the CE marking must be accompanied by the identification number of the notified body.

Legislation on implantable medical devices.

Legislation on healthcare products.

Legislation on in vitro diagnostic medical devices.

View information at: See information on: Product standards and requirements. Pharmaceutical industry

View information at: See information on: Product standards and requirements. Pharmaceutical industry

View information at: See information on: Product standards and requirements. Pharmaceutical industry