Registration, change of form and dissolution of a business: pharmaceutical sector

Pharmaceutical laboratories

To guarantee the quality of medicines, the system of licensing pharmaceutical laboratories which manufacture or import medicines, before they commence operations, ensures that all licensed medicines are manufactured by licensed entities that undergo periodic inspections to verify compliance with the standards of good manufacturing practice.

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• Licensing procedure for manufacturing/importing medicines

  Natural or legal persons engaged in the manufacture of medicines or investigational medicinal products or any of the processes involved, including fractionation, packaging and presentation for sale, are treated as manufacturing pharmaceutical laboratories and must be licensed in advance by the Spanish Agency of Medicines and Medical Devices (the AEMPS). Licensing is also necessary if the drug is manufactured exclusively for export.

  Licensing is a requirement for importing pharmaceutical laboratories that carry out the mandatory analyses for imports of medicines or investigational medicinal products that originate from third countries.

  An assessment, including AEMPS inspection, is conducted before manufacturing and/or importing activities are licensed.

  Requirements to be met by applicants for a licence for a manufacturing and/or importing pharmaceutical laboratory

  • They must specify which medicines they are going to manufacture or import, and in which pharmaceutical forms, as well as the place, plant or laboratory where it is manufactured or controlled.
  • They must have adequate and sufficient premises and technical and control equipment for the activity they intend to carry out. They must meet the legal requirements, both from the point of view of manufacturing and control and for storing and preserving the medicines.
  • They must have a technical director, a manufacturing manager and a quality control manager, all appropriately qualified. Laboratories that manufacture small quantities or simple products may assign the quality control function to the technical director, though a different person must hold responsibility for the manufacturing.

  Licensing application

  • Applications must be submitted to the AEMPS electronically, unless applicants can prove that the necessary technological resources are not available or accessible to them.
  • The documentation must be submitted at least in Spanish. Despite this requirement, the AEMPS may allow part(s) of the scientific and technical documentation to be submitted in another language.

  The following information and documentation must accompany a licensing application for a manufacturing or importing pharmaceutical laboratory:

  • Name or company name of the applicant and address or registered office, NIF or CIF (personal ID number or company tax code), and, in the case of legal entities, certification of registration in the commercial register with the activity which they intend to pursue being included in the corporate purpose.
  • Name of legal representative and accreditation of this representation.
  • A technical brief showing that they meet the requirements.
  • The nomination(s) of technical director(s) notified to the AEMPS must be signed by the laboratory's legal representative and by the nominated technical director, and accompanied by the following documents:

  Academic certificates proving that the nominated technical director meets the conditions prescribed by law;

  Documentation proving that the nominated technical director has the necessary experience;

  Nominated technical director’s declaration of non-debarment on any of the legal grounds;

  Evidence that the technical director is employed by the laboratory;

  • And proof of payment of the relevant fees under Royal Legislative Decree 1/2015 of 24 July 2015 approving the recast text of the Law on guarantees and rational use of drugs and health products.

  Once the file has been accepted for processing and assessed, a decision will be given, stating the grounds, and notified to the applicant within a maximum of 90 days from the date of receipt of the application by the AEMPS.

• Amendments of the drug manufacturing/import licence

  Amendments of the requirements prescribed in a licence as a manufacturing and/or importing pharmaceutical laboratory require prior AEMPS consent. Amendments must be submitted electronically via the AEMPS website , unless the applicant can prove that the necessary technological resources are not available or accessible to it.

  Administrative changes of the laboratory's particulars, such as the applicant’s name or company name and home address or registered office do not require permission, but do need to be notified to the AEMPS for issue of a new, updated licence.

  Applicants whose applications do not meet the set requirements will be asked to correct them within a 10-day period. They will be advised that, failing this, they will be deemed to have withdrawn the request.

  Application files accepted for processing will be assessed. For this purpose, the AEMPS may ask the applicant for extra documentation or clarification of any detail relating to the application. The time limit for submission of extra information is one month. The time limit for notification of the decision will be suspended until receipt of the requested information or expiry of the time limit allowed.

  An assessment precedes the amendment of a licence. This may include an AEMPS inspection to verify that the applicant possesses the appropriate human and material resources required to assure pharmaceutical quality in each operation covered by the application.

  If the application fails the assessment, the AEMPS will notify the applicant why the amendment applied for cannot be granted. The applicant then has 15 days to present a case and whatever documentation it considers appropriate.

  When the application passes the assessment, the AEMPS will issue the relevant decision granting permission. This will immediately be notified to the autonomous communities by any of the electronic or other media allowed by law.

  On completion of the examination procedure, the decision and grounds are issued and notified to the applicant, listing the resources required under the current regulations.

  The time limit for notification of the decision on the licence amendment procedures is 30 days from the date of receipt of the application by the AEMPS. Exceptionally, this may be extended to 90 days.

• Suspension and withdrawal of licence

  The AEMPS may agree to suspend or withdraw all or part of the licence of a manufacturing and/or importing pharmaceutical laboratory which ceases to meet the set requirements taken into account when granting the licence.

  Acting officially or at the request of a third party, the AEMPS may suspend or withdraw the licence of a pharmaceutical and/or importing laboratory.

  The time limit for notification of the decision on the procedure for suspension or withdrawal of the licence of a manufacturing and/or importing pharmaceutical laboratory is six months from the agreed start date or date of submission of the application.

  If it is agreed to suspend or withdraw the licence, the affected laboratory must stop its activities from the date of service of the decision. The AEMPS immediately informs the autonomous communities about such suspensions and withdrawals by electronic or any other means allowed by law.

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Manufacturers of active pharmaceutical ingredients

Companies that manufacture, import or distribute active substances must be entered in the public register set up for this purpose at the AEMPS in accordance with Article 25 of Royal Decree 824/2010 of 25 June regulating pharmaceutical laboratories, manufacturers of active substances for pharmaceutical use and the foreign trade of medicines and investigational medicinal products, amended by Royal Decree 782/2013 of 11 October 2013 on the distribution of medicines for human use .

Further information is available on the register of manufacturers, importers and distributors of active substances (RUESA).

Manufacturers, importers and distributors of active ingredients must also remember to give at least 60 days’ electronic notice of the planned date of commencement of their activities to the AEMPS, for assessment of the situation.

If the competent authority has not notified the applicant, within a time limit of 60 days from receipt of the registration form, that an inspection is to be carried out, the applicant can commence the activity.

These companies must also immediately notify the AEMPS of any change which may affect the quality or safety of the manufactured, imported or distributed active ingredients.

Companies manufacturing/importing/distributing active ingredients are also obliged to submit a declaration of their activities to the AEMPS by 31 January each year, by filling in the questionnaire provided for this purpose.

The declaration must be filed electronically via the AEMPS website, using the LABOFAR application, with payment of fee 3.13 ‘initial registration, notification of mandatory amendments or annual update of the register of manufacturers, importers and distributors of active substances’ . The procedure published in the LABOFAR application (‘RUESA – register of manufacturers, importers and distributors of active substances’) gives interested parties detailed instructions to help with their declarations.

Of course licensing as a pharmaceutical laboratory is not mandatory for these entities, except for the activities of manufacture of active ingredients which are sterile or of biological origin.

For more information, see Active Ingredients: manufacture, import, distribution.

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Plants for medical devices

The following companies/activities require an operating licence in advance:

• Manufacturers producing in series;
• Bespoke manufacturers;
• System assemblers;
• Sterilisers for third parties; and
• Importers

Of the following products:

• Medical devices and accessories;
• Active implantable medical devices;
• In vitro diagnostic medical devices and accessories;
• Non-corrective contact lenses not deemed to be medical devices;
• Apparatus and instrumentation used for invasive permanent and semi-permanent makeup or tattooing of the skin.

Bespoke manufacturing facilities and activities of natural or legal persons require a prior operating licence issued by the health authorities of the relevant autonomous community. The exceptions are the autonomous cities of Ceuta and Melilla.

The IPS INSTALACIONES PS application is available throughout the process of licence applications, amendments and renewals, from submission of the application and supporting documentation by the applicant until receipt of the relevant decision reached by the AEMPS.

See the Instructions on the procedure to follow to obtain a prior operating licence for plants for medical devices . Version: PS 1/2023.

See information on applying for login details for the application.

• Licensing procedure

  For a description, see the Instructions on the procedure to follow to obtain a prior operating licence for plants for medical devices. Version: PS 1/2023.

• Amendments to the licence

  Any amendment to the licence must be applied for and approved, in advance, by the AEMPS. Applicants must notify and apply for the amendments to be made, backed by the documentation and proof of payment of the applicable fee in each case.

  The AEMPS verifies that the amendment applied for meets the requirements of the relevant royal decree. This may necessitate inspection of the licensee company’s or its subcontractors’ premises.

  See Annex VI, the application form for an amendment to a prior operating licence. This is part of the Instructions on the procedure to follow to obtain a prior operating licence for plants for medical devices. Version: PS 1/2023.

• Refusal, suspension and withdrawal of licences

  The AEMPS may proceed to refuse, suspend or withdraw operating licences when the supplied documentation or relevant inspection reports do not corroborate that the company has the right facilities, resources, procedures and personnel to carry out the activities concerned, or when it no longer meets the conditions on which it was licensed.

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Cosmetics manufacturing and/or importing activities

Entities that need to submit a statement of compliance:

• Natural or legal persons that physically carry out the manufacture, packaging, packing and/or labelling of cosmetics in Spain.
• Importers of cosmetics originating from third countries.

The statement of compliance with cosmetics manufacturing and import activities covers the activities for which the owner is responsible, either because they take place in its own plant, or in the plants of subcontractors for which it assumes responsibility.

The company states that its factory conforms to good manufacturing practices and complies with the requirements established for the pursuit of its activity.

The statement of compliance must preferably be submitted electronically via the AEMPS website, using the application for t he statement of compliance with cosmetics manufacturing and import activities [Declaración Responsable de Actividades de Fabricación e Importación de Cosméticos]. Follow the instructions on the application given in the manual for companies.

Activities can commence from the date of submission of the statement of compliance, without prejudice to subsequent corroboration by the AEMPS by documentary verification and, where applicable, inspection of the evidence and circumstances presented by the interested party in the statement of compliance.

• Amendments

  The statement of compliance must also be submitted if the activity changes substantially. This means a move of facilities in which the activity is carried out, including new plants or extensions of facilities, and manufacture of new forms of cosmetics.

  The owner or its legal representative must notify any other change of the declared particulars to the AEMPS by submission of a declaration updating the particulars.

• Cessation of activities

  The owner or its legal representative must notify the cessation of manufacturing and/or import activities using the COSMET2_DR application.

• Exemptions from submitting a statement of compliance

  • Distributors of cosmetics already introduced to the market in the European Union;
  • companies or facilities subcontracted to provide storage and/or control for manufacturers and importers;
  • pharmacy laboratories which develop cosmetics exclusively for sale in their own pharmacy;
  • and establishments which fractionate bulk cosmetics designed by the manufacturer for fractionation, for sale to the public, such as colognes and solid soaps.

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Businesses manufacturing and/or importing personal care products

Natural or legal persons which physically carry out the manufacture, packaging, packing and/or labelling of personal care products in Spain and importers of these products originating from third countries must complete a declaration by the person responsible for the activities to the AEMPS before the start of the activity.

See the Instructions on completing the statement of compliance for personal care products.

Access to the COSMET computer application for the electronic submission of statements of compliance for businesses manufacturing and/or importing personal care products.

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Manufacturing, import or storage of biocides under the AEMPS

Entities and facilities established in Spain that manufacture, import and/or store biocides under the AEMPS must be licensed for their activities.

They must submit an application to the AEMPS with proof of payment of the fees.

The written application must contain the data relating to the company and its activities and information on the products manufactured, packed, packaged, labelled, imported, stored and/or controlled.

The written application must be accompanied by a description of the activity carried out and the human and material resources available for this purpose.

The AEMPS assesses the submitted documentation and carries out or orders the appropriate inspections.

This documentation must be filed at the electronic registry.

See the documents:

Instructions on the procedure to follow for the licensing of insect repellent manufacture, import and/or storage (pesticides for use in personal hygiene)

• Amendments

  Any amendment to the conditions on which an activity licence was obtained must be authorised by the AEMPS. For this purpose, companies must notify amendments to be made, by submitting an application duly signed by their legal representative and technical manager, backed by the documentation appropriate in each case and proof of payment of the relevant fee.

• Renewal

  The period of validity stated in the relevant licensing document is 5 years from the licence date, unless the licence issued is subject to special terms and/or conditions, for justified reasons.

  Companies wanting to maintain the validity of their activity licences must apply for renewal to the AEMPS 3 months before the set expiry date. The written application must be accompanied by proof of payment of the relevant fee and the original licence document, which will be returned to the company after due processing.

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Información por Comunidades Autónomas