Medicinal Products Licensing Ordinance (MPLO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Inspections
Art. 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 be accredited.
Art. 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 independent of the companies that they are in charge of inspecting. If this is not the case, they must recuse themselves.
Article 58Recognition of inspectorates
1 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 inspectorates that fulfil these requirements.
Art. 59 Cantonal obligation to notify
The cantons must notify Swissmedic of any changes within their inspectorates.
Art. 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 manufacturers of medicinal product abroad and facilities abroad that engage in wholesale trading in medicinal products, at the importing company’s expense. It informs this company in advance. 3 In those States with which Switzerland has signed an agreement for the mutual recognition of GMP systems, Swissmedic only carries out inspections in justified exceptional cases and after consultation with the competent healthcare authorities in that State.
Art. 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 standards of good practice recognised in Switzerland.
Art. 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 or without prior notification and, if required, take photographs; c. make copies of documents, including data saved on electronic data storage media or in part of a computer system; d. take samples of medicinal products, raw materials, intermediate products, packaging material or materials used in the manufacturing process; and e. take all necessary immediate measures.
Art. 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.
Section 2 Collaboration between Swissmedic and oth
Art. 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 about: a. the granting, amendment, suspension or withdrawal of a licence; b. measures taken; c. inspections. 3 The cantonal authorities provide Swissmedic with any information brought to their attention that indicates quality or safety defects. 4 Swissmedic may assist the cantonal inspectorates in training their inspectors.
Art. 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 import, export and transit of medicinal products. 3 Swissmedic may require the customs authorities to detain medicinal products for further inspection and take samples.
Section 3 Data protection and Informing the Genera
Art. 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: a. health data recorded in connection with the official market surveillance of blood and blood products (Art. 39, 58 and 59 TPA); b. data on administrative and criminal proceedings or sanctions that are relevant to the assessment of licence applications, specifically in assessing whether a responsible person is appropriate for this task.
let. b — Amended by Annex 2 No II 98 of the Data Protection Ordinance of 31 Aug. 2022, in force since 1 Sept. 2023 (AS 2022 568).
Art. 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 system. In this policy, it establishes the technical and organisational measures used to ensure the security and protection of the processed data. 3 If it transfers activities to third parties, it ensures compliance with data security requirements by means of a contract.
Art. 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 be kept for no longer than two years and separate from the system in which the personal data is processed.
Para. 2 — Amended by Annex 2 No II 98 of the Data Protection Ordinance of 31 Aug. 2022, in force since 1 Sept. 2023 (AS 2022 568).
Art. 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.
Art. 70 Informing the public about licences
Swissmedic regularly publishes lists with the information specified in Annex 7.