Corporate mergers or acquisitions: pharmaceutical sector
Content
Pharmaceutical laboratories
Where the merger or sale of a company entails issuing a new health permit, the same authorisation procedure shall be followed for pharmaceutical laboratories.
See information on: starting up, managing and closing a business. Registration, change of legal form or closure of a business .
Manufacturers of active substances for pharmaceutical use
The same procedure shall be followed for registering manufacturers of active substances for pharmaceutical use.
See information on: starting up, managing and closing a business. Registration, change of legal form or closure of a business .
Healthcare product facilities
The merger or sale of the company entails issuing a new health licence; accordingly, the same procedure for applying to modify the previous operating licence shall be followed for healthcare product facilities.
Where to carry out corporate mergers:
When applying for a licence modification, there is a specific section for corporate mergers in the ‘ Instalaciones de productos sanitarios, IPS
’ (healthcare product facilities) application.
For the merger or sale of a company, a notarial act must be produced proving:
- the merger or sale of the company,
- and stating that the same facilities, staff, and resources will be maintained.
Businesses manufacturing and/or importing cosmetics
Any change in the data declared means a statement of compliance with the established procedures must be submitted.
See information on: starting up, managing and closing a business. Registration, change of legal form or closure of a business .
Businesses manufacturing and/or importing personal care products
Any change in the data declared means a statement of compliance with the established procedures must be submitted.
See information on: starting up, managing and closing a business. Registration, change of legal form or closure of a business .
Manufacturing, import or storage of biocides under the AEMPS
Where it entails issuing a new health permit, the same authorisation procedure shall be followed for manufacturing, importing, or storing biocides under the AEMPS.
See information on: starting up, managing and closing a business. Registration, change of legal form or closure of a business .
Legal and/or technical references
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General Health Law 14/1986 of 25 April
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Law 39/2015 of 1 October on the Common Administrative Procedure of the Public Administrations
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Royal Legislative Decree 1/2015 of 24 July approving the recast text of the Law on guarantees and rational use of drugs and health products
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Royal Decree 824/2010 of 25 June regulating pharmaceutical laboratories, manufacturers of active substances for pharmaceutical use and foreign trade in medicines and investigational medicinal products
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Legislation on industry and distribution
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Royal Decree 1591/2009 of 16 October regulating healthcare products
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Royal Decree 1616/2009 of 26 October regulating active implantable medical devices
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Royal Decree 1662/2000 of 29 September on in vitro diagnostic medical products
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Royal Decree 437/2002 of 10 May laying down the criteria for granting operating licences to manufacturers of customised health products
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Instruction on the procedure to be followed for obtaining a preliminary operating licence for healthcare product facilities (Version PS 1/2023)
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Royal Decree 85/2018 of 23 February regulating cosmetics
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Statement of compliance for businesses manufacturing or importing cosmetics (V.8-9/2019)
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Instructions for completing the statement of compliance for personal care products
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Royal Decree 1054/2002 of 11 October regulating the evaluation process for the registration, authorisation and marketing of biocides
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Royal Decree 3349/1983 of 30 November amending the Technical Health Regulations for the manufacture, marketing and use of pesticides
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Order SCO/3269/2006 of 13 October 2007 laying down the basis for the registration and operation of the Official Register of Biocidal Establishments and Services
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Instructions on the procedure to be followed for authorising businesses manufacturing, importing, or storing insect repellent products (pesticides for use in personal hygiene)
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Instructions on the procedure to be followed for authorising businesses manufacturing, importing, or storing disinfectants for clinical use – intact skin antiseptics
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
