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

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 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.

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.

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.

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.

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.

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.

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

• 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.

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.

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.