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Document textGeneral document text1ArticlesRegular articles in this version74AnnexesAnnexes and attachments in this version8Additional contentsOther structured content in this version1
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Articles74
1Chapter 1 Subject Matter and Definitions
Art. 1 – Object and definition of termsArt. 1 Object and definition of terms 1 This Ordinance regulates: a. the manufacture of medicinal products; b. wholesale trading in medicinal products; c. the import, export and transit trade in medicinal products; d. t… Direct link
Art. 2 – DefinitionsArt. 2 Definitions In this Ordinance: a. active pharmaceutical ingredients means substances or mixtures to which the effect of a ready-to-use medicinal product is attributed and which are used in ready-to-use medicinal… Direct link
1Chapter 2 Establishment Licences
2Section 1 Manufacturing Licence
Art. 3 – Conditions for granting a licenceArt. 3 Conditions for granting a licence 1 Any person applying to the Swiss Agency for Therapeutic Products (Swissmedic) for a manufacturing licence must prove that: a. a system to ensure the pharmaceutical quality of m… Direct link
Art. 4 – Responsibility and Good Manufacturing PracticeArt. 4 Responsibility and Good Manufacturing Practice 1 Holders of a licence under Article 3 are responsible for the processing and working procedures they carry out. 2 Medicinal product manufacture must be carried out… Direct link
Art. 5 – Technical supervision of the facilitiesArt. 5 Technical supervision of the facilities 1 The Responsible Person is responsible for the direct technical supervision of the facilities and in particular ensures that the medicinal products are handled appropriate… Direct link
Art. 6 – Individual requirements that the Responsible Person must fulfilArt. 6 Individual requirements that the Responsible Person must fulfil 1 The Responsible Person must have the necessary technical knowledge and be trustworthy. They must also fulfil the following professional requiremen… Direct link
Art. 7 – Technical releaseArt. 7 Technical release 1 The Responsible Person decides on the technical release of a product batch. 2 They issue a batch certificate confirming that the batch in question conforms to the requirements of internal or e… Direct link
Art. 8 – Cantonal manufacturing licenceArt. 8 Cantonal manufacturing licence 1 Hospital pharmacists and persons in possession of a cantonal licence in accordance with Article 30 TPA who prepare medicinal products in accordance with Article 9 paragraph 2 lett… Direct link
Art. 9 – Surveys of medicinal products prepared in accordance with Article 9 paragraph 2 letters a–cbis TPAArt. 9 Surveys of medicinal products prepared in accordance with Article 9 paragraph 2 letters a–cbis TPA The cantons may conduct surveys among manufacturers concerning the medicinal products prepared in accordance with… Direct link
Art. 10 – Cantonally authorised medicinal productsArt. 10 Cantonally authorised medicinal products The preparation of medicinal products in accordance with Article 9 paragraph 2 letter f TPA is exempt from licensing by Swissmedic. Direct link
2Section 2 Licence for the Import, Wholesale Trade and Export of Medicinal Products
Art. 11 – General preconditionsArt. 11 General preconditions 1 Any person applying for a licence to import medicinal products must prove that: a. a system to ensure the pharmaceutical quality of medicinal products is in operation and that the company… Direct link
Art. 12 – Additional preconditionsArt. 12 Additional preconditions 1 Any person who applies for a licence to trade wholesale in medicinal products or a licence to import ready-to-use medicinal products, and who in addition wishes to release ready-to-use… Direct link
Art. 13 – Market releaseArt. 13 Market release 1 The Responsible Person employed by the holder of the marketing authorisation decides on the market release of a batch before it is placed on the market. 2 They check whether: a. a valid batch ce… Direct link
Art. 14 – ReanalysisArt. 14 Reanalysis If ready-to-use medicinal products are manufactured in a State with which Switzerland has not signed an agreement on the mutual recognition of the GMP control procedures and there are justified doubts… Current article Direct link
Art. 15 – Responsibility and Good Distribution PracticeArt. 15 Responsibility and Good Distribution Practice 1 Holders of a licence under Article 11 bear responsibility for the activities they carry out. 2 The import, export and wholesale trading of medicinal products must… Direct link
Art. 16 – Mandatory documentationArt. 16 Mandatory documentation Licence holders must keep the following documents in particular in order to ensure traceability: a. the name of the medicinal product; b. the transaction date; c. the quantity; d. the bat… Direct link
Art. 17 – Technical supervision of the facilitiesArt. 17 Technical supervision of the facilities 1 The Responsible Person is responsible for the direct technical supervision of the facilities and in particular ensures that the medicinal products are handled appropriat… Direct link
Art. 18 – Individual requirements that the Responsible Person must fulfilArt. 18 Individual requirements that the Responsible Person must fulfil 1 The Responsible Person must have the necessary training, technical knowledge and experience, and be trustworthy. 2 To obtain a licence in accorda… Direct link
Art. 19 – Import of non-authorised medicinal products for clinical trialsArt. 19 Import of non-authorised medicinal products for clinical trials 1 The import of medicinal products for use in a clinical trial in accordance with the protocol for that trial requires a licence issued by Swissmed… Direct link
Art. 20 – Exemption from mandatory licensingArt. 20 Exemption from mandatory licensing 1 Doctors and veterinary surgeons who practise their profession on both sides of the border in accordance with current international agreements may import and export ready-to-u… Direct link
2Section 3 Licence for Trading in Foreign Countries
Art. 21 – PreconditionsArt. 21 Preconditions 1 Any person applying for a licence to trade in foreign countries must prove that: a. the facilities operate a system to ensure the pharmaceutical quality of medicinal products and that the company… Direct link
Art. 22 – Due diligenceArt. 22 Due diligence 1 Holders of a licence under Article 21 are responsible for the correct conduct of trade with medicinal products and the traceability of the buying and selling of medicinal products. 2 They ensure… Direct link
Art. 23 – Technical supervision and Responsible PersonArt. 23 Technical supervision and Responsible Person 1 Responsible Persons carry out the direct technical supervision of the facilities and, in particular, ensure orderly trading in medicinal products. 2 They are author… Direct link
2Section 4 Licence to perform Brokerage or Agency Activities
Art. 24 – PreconditionsArt. 24 Preconditions 1 Any person applying for a licence to perform brokerage or agency activities must prove that: a. the facilities operate a functioning quality assurance system and that the company management and s… Direct link
Art. 25 – Due diligenceArt. 25 Due diligence 1 Holders of a licence in accordance with Article 24 must ensure that the supplier and the customer are authorised to carry out the work processes that they perform. They must be able to prove this… Direct link
Art. 26 – Technical supervision and Responsible PersonArt. 26 Technical supervision and Responsible Person 1 Responsible Persons carry out the direct technical supervision of the facilities and in particular ensure compliance with due diligence within the facilities. 2 The… Direct link
2Section 5 Special Provisions for Blood and Blood Products
Art. 27 – Conditions for granting a licence for the collection of bloodArt. 27 Conditions for granting a licence for the collection of blood 1 Any person applying for a licence to collect blood for transfusion or the manufacture of medicinal products in accordance with Article 34 TPA must… Direct link
Art. 28 – Responsible Person for haemovigilanceArt. 28 Responsible Person for haemovigilance 1 The holder of a licence for activities with blood or labile blood products must appoint a person responsible for haemovigilance. 2 The Responsible Person must be a doctor… Direct link
Art. 29 – Donor suitabilityArt. 29 Donor suitability 1 The suitability of blood donors must be evaluated by a qualified physician with experience in transfusion medicine or by a person trained in this assessment who is working under the supervisi… Direct link
Art. 30 – Compulsory testingArt. 30 Compulsory testing 1 A sample of every collected blood donation used for transfusion or to manufacture labile blood products must be tested in accordance with the testing requirements listed in Annex 5 number 2.… Direct link
Art. 31 – Appropriate tests and test proceduresArt. 31 Appropriate tests and test procedures 1 If the tests are carried out abroad, it must be proven that they comply with the state-of-the-art scientific and technological knowledge. 2 Swissmedic may specify technica… Direct link
Art. 32 – Procedure in the event of a positive test resultArt. 32 Procedure in the event of a positive test result 1 If the test is repeatedly reactive, the blood donation may not be used for transfusion or to manufacture blood products. 2 If further confirmation tests on bloo… Direct link
Art. 33 – Donor counsellingArt. 33 Donor counselling 1 The donor may only be informed of a positive test result if the test has been confirmed using an appropriate method. 2 Where a donor is informed of a positive test result, they must also be o… Direct link
Art. 34 – LabellingArt. 34 Labelling 1 Blood and labile blood products and the corresponding blood samples must be labelled in accordance with the rules of GMP and good practice in accordance with Annex 1 of the Ordinance of 29 April 2015… Direct link
Art. 35 – Records and traceabilityArt. 35 Records and traceability 1 Holders of a licence for handling blood and labile blood products must maintain records of all safety-relevant activities, in particular in relation to the collection of blood, and the… Direct link
Art. 36 – Archiving and transmitting dataArt. 36 Archiving and transmitting data 1 If the holder of a licence to handle blood and labile blood products ceases this activity prior to expiry of the archiving obligation in accordance with Article 40 TPA, the arch… Direct link
Art. 37 – Protective measuresArt. 37 Protective measures 1 Holders of a licence to handle blood or labile blood products must immediately take the necessary protective measures if they notice that: a. at the time of donation the donor did not fulfi… Direct link
Art. 38 – Additional safety measuresArt. 38 Additional safety measures 1 Blood and labile blood products may only be used for homologous transfusions if the leucocytes have been depleted in a validated state-of-the-art scientific or technical procedure. 2… Direct link
1Chapter 3 Licensing Procedure
Art. 39 – Granting the licenceArt. 39 Granting the licence 1 The licence is granted if: a. the application is complete; b. the applicant fulfils all relevant conditions at all facilities for the activities applied for. 2 Swissmedic shall suspend the… Direct link
Art. 40 – Content of the licenceArt. 40 Content of the licence The licence specifies the name of the Responsible Person, the licensed activities and the site of the facilities. It may not be transferred to other persons or to other sites. Direct link
Art. 41 – AmendmentsArt. 41 Amendments 1 Holders of a licence must apply to Swissmedic with the necessary documentation for any amendments to the content of the licence. 2 They must report the essential details of all major changes to faci… Direct link
Art. 42 – Periodic reviewArt. 42 Periodic review 1 Fulfilment of all the conditions for retaining the licence is reviewed periodically by inspection. 2 If the conditions are no longer fulfilled or if their fulfilment cannot be examined, specifi… Direct link
Art. 43 – Detailed specificationsArt. 43 Detailed specifications Swissmedic may specify the terms of the licensing procedure in greater detail. Direct link
1Chapter 4 Special Provisions for Import, Export, Transit and Trading Abroad
Art. 44 – Import of individual batches of immunological medicinal products that are authorised or not subject to authorisation or of blood and blood productsArt. 44 Import of individual batches of immunological medicinal products that are authorised or not subject to authorisation or of blood and blood products 1 Any person who imports the following medicinal products that… Direct link
Art. 45 – Conditions for granting a licenceArt. 45 Conditions for granting a licence Any person applying for a licence in accordance with Article 44 paragraph 1 must prove that: a. they have a licence to import medicinal products; b. if these are ready-to-use me… Direct link
Art. 46 – ProcedureArt. 46 Procedure 1 The application for a licence to import individual batches must be submitted to Swissmedic together with the necessary documentation. 2 The licence is valid for one month. 3 The applicant must ensure… Direct link
Art. 47Art. 47 Repealed by Annex No 1 of the O of 23 Nov. 2022, with effect from 1 Jan. 2023 (AS 2022 723). Repealed by Annex No 1 of the O of 23 Nov. 2022, with effect from 1 Jan. 2023 (AS 2022 723). Direct link
Art. 48 – Import of non-authorised ready-to-use medicinal products by individualsArt. 48 Import of non-authorised ready-to-use medicinal products by individuals Individuals may import ready-to-use medicinal products that are not authorised in Switzerland in quantities needed for their personal use.… Direct link
Art. 49 – Import of non-authorised ready-to-use medicinal products by professionalsArt. 49 Import of non-authorised ready-to-use medicinal products by professionals 1 A medical professional who has a cantonal dispensing licence may import small quantities of a ready-to-use human medicinal product that… Direct link
Art. 49a – Import of non-authorised ready-to-use medicinal products by intergovernmental organisations and international institutionsArt. 49a Inserted by No I of the O of 12 Feb. 2025, in force since 15 March 2025 (AS 2025 109). Inserted by No I of the O of 12 Feb. 2025, in force since 15 March 2025 (AS 2025 109). Import of non-authorised ready-to-us… Direct link
Art. 50 – Medicinal products that can be used for capital punishmentArt. 50 Medicinal products that can be used for capital punishment 1 Any person who exports medicinal products that can be used for capital punishment requires a licence from Swissmedic for each transaction. 2 Any perso… Direct link
Art. 51 – TransitArt. 51 Transit The transit of medicinal products which are dangerous to health is not permitted. Direct link
1Chapter 5 Temporary licences to use medicinal products in accordance with Art. 9b para. 1 TPA
Art. 52 – PreconditionsArt. 52 Preconditions 1 A temporary licence to use medicinal products in accordance with Article 9b paragraph 1 TPA may be granted to the sponsor of a clinical trial approved in Switzerland if the sponsor: a. confirms t… Direct link
Art. 53 – Procedure for granting and extending a licenceArt. 53 Procedure for granting and extending a licence 1 The application is submitted to Swissmedic with the documents listed in Annex 6. 2 Swissmedic may request additional information. 3 It informs the Ethics Committe… Direct link
Art. 54 – PreconditionsArt. 54 Preconditions 1 The sponsor notifies Swissmedic of all major changes affecting the medicinal product or its usage by analogy with Article 34 paragraph 3 letters a‑c of the Ordinance of 20 September 2013SR 810.30… Direct link
Art. 55 – Withdrawal of the licenceArt. 55 Withdrawal of the licence 1 Swissmedic may withdraw the licence in the interest of protecting patients’ health. 2 The announcement of a final Swissmedic decision rejecting the application for a licence to place… Direct link
1Chapter 6 Implementation
2Section 1 Inspections
Art. 56 – Requirements pertaining to inspectoratesArt. 56 Requirements pertaining to inspectorates Inspectorates that conduct inspections by virtue of this Ordinance must have a quality management system that complies with internationally recognised standards and must… Direct link
Art. 57 – Requirements pertaining to inspectorsArt. 57 Requirements pertaining to inspectors 1 Inspectors must have an appropriate university degree in the relevant field or a comparable qualification, together with experience and regular training. 2 They must be in… Direct link
Art. 58 – Cantonal obligation to notifyArt. 59 Cantonal obligation to notify The cantons must notify Swissmedic of any changes within their inspectorates. Direct link
Art. 59 – Ordering and conduct of inspectionsArt. 60 Ordering and conduct of inspections 1 The competent authority may at any time order inspections in Switzerland or carry them out themselves whenever they consider this necessary. 2 Swissmedic may inspect manufac… Direct link
Art. 60 – Issuing certificatesArt. 61 Issuing certificates At the request of facilities inspected in Switzerland or abroad in accordance with Article 60, Swissmedic may confirm by means of a certificate that the facilities are in conformity with the… Direct link
Art. 61 – Powers of the inspectorsArt. 62 Powers of the inspectors The inspectors may: a. demand a current description of the facilities in the form of a Site Master File from the company to be inspected; b. enter any part of a company's facilities with… Direct link
Art. 62 – Guidelines on the Swiss inspection systemArt. 63 Guidelines on the Swiss inspection system After consultation with the inspectors appointed by the cantons, Swissmedic issues guidelines to guarantee uniform inspection procedures throughout Switzerland. Direct link
2Section 2 Collaboration between Swissmedic and other authorities
Art. 63 – Collaboration between Swissmedic and the cantonsArt. 64 Collaboration between Swissmedic and the cantons 1 Swissmedic and the cantonal authorities collaborate in their control work and may in particular exchange confidential information. 2 They notify each other abou… Direct link
Art. 64 – Collaboration with the customs authoritiesArt. 65 Collaboration with the customs authorities 1 Customs clearance for imports, exports and goods in transit is governed by customs legislation. 2 The customs authorities provide Swissmedic with information on the i… Direct link
2Section 3 Data protection and Informing the General Public
Art. 65 – Processing personal dataArt. 66 Processing personal data The organs responsible for enforcement are authorised to process the personal data that they require for performing all the tasks assigned to them by this Ordinance. These data include:… Direct link
Art. 66 – Operating information systemsArt. 67 Operating information systems 1 Swissmedic is responsible for the secure operation of its information systems and the lawfulness of its data processing. 2 It issues a processing policy for each information syste… Direct link
Art. 67 – Access rightsArt. 68 Access rights 1 Employees of Swissmedic have online access to the information systems to the extent necessary for them to perform their tasks. 2 Access to the information systems shall be logged. Such logs shall… Direct link
Art. 68 – Archiving and deletion of dataArt. 69 Archiving and deletion of data Swissmedic retains personal data in its information systems for no longer than ten years. The data are deleted as soon as they are no longer required to perform a task. Direct link
Art. 69 – Informing the public about licencesArt. 70 Informing the public about licences Swissmedic regularly publishes lists with the information specified in Annex 7. Direct link
1Chapter 7 Final Provisions
Art. 70 – Amendments to the annexesArt. 71 Amendments to the annexes 1 The Federal Department of Home Affairs may adapt the annexes to this Ordinance to take account of international or technical developments. 2 Amendments that could constitute technical… Direct link
Art. 71 – Repeal and amendment of other legislationArt. 72 Repeal and amendment of other legislation The repeal and amendment of other legislation are covered in Annex 8. Direct link
Art. 72 – Transitional provisionsArt. 73 Transitional provisions 1 Licences granted under the previous law retain their validity no longer than the date on which they expire. The application to renew a licence must be submitted spontaneously to Swissme… Direct link
Art. 73 – CommencementArt. 74 Commencement 1 This Ordinance comes into force on 1 January 2019 subject to paragraph 2. 2 Article 20 paragraphs 2–4 come into force on 1 January 2020. Direct link
Annexes8
International rules of Good Manufacturing PracticeAnnex 1 (Art. 4 para. 2, 7 para. 2, 13 para. 2 let. a, 27 para. 1 let. c, 37 para. 1 let. e, 45 let. d) International rules of Good Manufacturing Practice 1. The following guidelines apply as rules of Good Manufacturing…Direct link
Rules of Good Manufacturing Practice for medicinal products in small quantitiesAnnex 2 (Art. 4 para. 2, 8 para. 4) Rules of Good Manufacturing Practice for medicinal products in small quantities The provisions of Chapters 20.1 and 20.2 of the Pharmacopoea Helvetica (Ph. Helv.) apply as rules of Go…Direct link
Risk assessment for the preparation of medicinal products specified in Article 9 paragraph 2 letters a–c bis TPAAnnex 3 (Art. 8 para. 1–3) Risk assessment for the preparation of medicinal products specified in Article 9 paragraph 2 letters a–c bis TPA 1 Calculation of the risk factor The risk factor should always be calculated fo…Direct link
International rules of Good Distribution PracticeAnnex 4 (Art. 13 para. 2 let. d, 15 para. 2, 17 para. 2, 20 para. 3, 45 let. d, 49 para. 5) International rules of Good Distribution Practice The following guidelines apply as rules of Good Distribution Practice (GDP):…Direct link
Donor suitability, test procedures and information about donating bloodAnnex 5 (Art. 29 para. 3 and 5, 30 para. 1, 32 para. 2) Donor suitability, test procedures and information about donating blood 1 Evaluation of donor suitability Recommendation R (95) of the Council of Europe of 12 Octo…Direct link
Documentation required for a temporary licence to use medicinal products in accordance with Article 9 paragraph 1 TPAAnnex 6 (Art. 53 para. 1) Documentation required for a temporary licence to use medicinal products in accordance with Article 9 b paragraph 1 TPA 1. Application for a temporary licence for use, including a reference to…Direct link
Provision of information about licences to the publicAnnex 7 (Art. 70) Provision of information about licences to the public The lists contain the following information: a. name and address of the licence holder; b. facility sites; c. licensed activities; d. date of last…Direct link
Repeal and amendment of other legislationAnnex 8 (Art. 72) Repeal and amendment of other legislation I The Medicinal Products Licensing Ordinance of 17 October 2001 is repealed. II The ordinances listed below are amended as follows: ...Direct link
Additional contents1
Article 58Recognition of inspectorates1 Swissmedic checks and supervises whether the cantonal inspectorates mandated to carry out inspections in accordance with Article 60 TPA fulfil the requirements described in Articles 56 and 57. 2 It recognises the insp…Direct link

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