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 Manufacturing Licence
Art. 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 medicinal products is in operation and that the company management and staff in the individual departments concerned take an active part in such a system; b. each department has a sufficient number of qualified and competent staff members to enable it to achieve its quality targets; c. a Responsible Person as described in Articles 5 and 6 is available; d. the facilities are organised in an appropriate way; e. the facilities are designed, structured, maintained and modernised regularly to guarantee the safe manufacture of medicinal products and the premises and equipment that can influence the quality of the medicinal products are qualified for their purpose; f. a documentation system is available to provide the working instructions, process descriptions and protocols of the relevant manufacturing procedures; g.
Art. 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 in accordance with the rules of Good Manufacturing Practice described in Annex 1 or 2. 3 In the manufacture of complementary medicinal products, the GMP rules must be followed by analogy and the specific regulations for the therapies concerned which are laid down in the pharmacopoeias recognised by Swissmedic must be adhered to.
Art. 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 appropriately. 2 They are responsible for the quality of the manufactured medicinal products and ensure that the legal provisions applicable to therapeutic products are observed. 3 They are authorised to issue instructions within their sphere of activity. 4 They and the company management jointly ensure their deputisation by adequately qualified specialists. 5 If the facilities cease operations, or if operations can be expected to cease imminently, the Responsible Person must report this situation to Swissmedic without delay. 6 They may not sit on one of the facilities’ supervisory committees and must decide on the release or rejection of batches independently of the company’s management. Swissmedic may grant a licence to small facilities without such segregation if they cannot implement the segregation because of their size. 7
Art. 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 requirements: a. for the manufacture of ready-to-use medicinal products or intermediate products, the Responsible Person must be a qualified pharmacist with professional experience; b. for the manufacture of labile blood products or immunological medicinal products the Responsible Person must have a university degree in medicine or a life science and have the necessary professional experience; c. for the manufacture of active pharmaceutical ingredients or medicated feedingstuffs, the Responsible Person must have a university degree in a life science and the necessary professional experience; d. for the manufacture of radiopharmaceuticals, the Responsible Person must have a certificate issued by the European Association of Nuclear Medicine for Radiopharmacy and have the necessary experience. 2 If a person can prove sufficient knowledge and experience,
Art. 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 external clients in terms of composition, manufacturing procedure, specifications and quality and was manufactured in compliance with the GMP rules in accordance with Annex 1 or 2.
Art. 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 letters a–cbis or paragraph 2bis TPA must carry out a risk assessment in accordance with Annex 3. This provision does not apply to the cases set out in paragraph 6 below. 2 The conduct of these risk assessments should be documented. This documentation should be presented to the cantonal supervisory authority on request. 3 If the risk assessment produces a value below the threshold specified in Annex 3, a cantonal manufacturing licence is required instead of a licence issued by Swissmedic. 4 The licence is granted if it can be ensured that the rules of Good Manufacturing Practice for small quantities of medicinal products in accordance with Annex 2 are observed. 5 The cantons regulate the other conditions for the granting of the licence in accordance with paragraph 3 and periodically carry out facility checks. 6
Art. 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 Article 9 paragraph 2 letters a–cbis and paragraph 2bis TPA. The manufacturers are obliged to provide the necessary information to the cantons on request.
Art. 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.
Section 2 Licence for the Import, Wholesale Trade
Art. 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 management and staff in the individual departments concerned take an active part in such a system; b. each department has a sufficient number of qualified and competent staff members to enable it to achieve its quality targets; c. the tasks of all persons occupying key positions in the company are set out in job descriptions and their hierarchical positions are set out in organisational charts; d. a Responsible Person in accordance with Articles 17 and 18 is available; e. the facilities are organised in an appropriate way; f. the facilities are designed, structured, maintained and modernised regularly to guarantee the safe import of medicinal products; g. a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant import procedures;
Art. 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 medicinal products onto the market in their capacity as holder of the marketing authorisation must fulfil the requirements stated in Article 11 and also ensure that: a. an analysis sample sufficient for two complete release analyses is kept of each batch of a medicinal product released onto the market; b. an inspection sample is available for each batch of a medicinal product; c. general and batch-specific documentation of the manufacture of a medicinal product, including documentation of its technical release and testing, is available; d. a person is appointed for pharmacovigilance who has the appropriate specialist knowledge and is in charge of reporting adverse drug reactions in accordance with Articles 61 and 65 of the Therapeutic Products Ordinance of 21 September 2018 (TPO); e. the requirements d
Para. 1 let. d — SR 812.212.21
Art. 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 certificate issued by the manufacturer is available and whether the batch was manufactured in conformity with the GMP rules described in Annex 1; b. the batch in question fulfils the requirements of the authorisation; c. the conditions described in Articles 11 and 12 have been fulfilled; and d. the entire supply chain is in conformity with the authorisation and the GDP rules described in Annex 4. 3 Swissmedic may specify additional checks. 4 The Responsible Person confirms that the checks described in paragraphs 2 and 3 have been performed.
Para. 2 let. d — Stands for: Good Distribution Practice
Art. 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 about the safety or quality of the batches to be imported, Swissmedic may order that each batch undergo reanalysis in Switzerland.
Art. 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 conform to the GDP rules described in Annex 4.
Para. 2 — Amended by No I 1 of the O of 12 Jan. 2022 on Amendments related to the new EU Veterinary Medicinal Products Law, in force since 28 Jan. 2022 (AS 2022 16).
Art. 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 batch number; e. the expiry date; f. the name and address of the supplier and the customer.
Art. 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 appropriately. 2 They ensure that the import, export and wholesale trading in medicinal products are in conformity with the GDP rules described in Annex 4 and ensure that the legal provisions applicable to therapeutic products are observed. 3 They are authorised to issue instructions within their sphere of activity. 4 They and the company management jointly ensure their deputisation by adequately qualified specialists. 5 If the facilities cease operations, or if operations can be expected to cease imminently, they must report this situation to Swissmedic without delay. 6 They may not sit on one of the facilities’ supervisory committees and must decide on the release or rejection of batches independently of the company’s management. Swissmedic can grant a licence to small facilities without such segregation if they cannot implem
Art. 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 accordance with Article 12 paragraphs 1 and 3, the Responsible Person must also fulfil the following requirements and tasks: a. The Responsible Person must possess a degree in pharmacology and the necessary experience in the manufacture of ready-to-use medicinal products. If the person can prove sufficient knowledge and experience in the medicinal products sector, Swissmedic may also recognise other professional qualifications for this job. b. In granting market release, the Responsible Person ensures that each batch is not placed on the Swiss market until all the applicable conditions of Articles 11–13 have been fulfilled and the entire supply chain is in conformity with the authorisation and the GDP rules. 3 Swissmedic may specify further details to Article 17 and this Article, in particular the minimum number of hours during which the Responsibl
Para. 2 — Correction of 28 May 2019 (AS 2019 1605).
Art. 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 Swissmedic. This licence also covers the individual import of immunological medicinal products and of blood and blood products. 2 A licence is not required if the importing person or institution already holds a licence as described in Article 11.
Art. 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-use medicinal products in small quantities without a licence insofar as this is indispensable for practising their profession. 2 Any person holding a cantonal licence to dispense medicines as a public pharmacy, hospital pharmacy or drugstore does not require an operating licence from Swissmedic for the wholesale trade in medicines occasionally conducted with other holders of a cantonal dispensing licence in the canton in which they are established. If the medicines are sold to more than five customers a year or if distribution is transferred to a third party, an operating licence from Swissmedic is required. 3 For wholesale trade activities in accordance with paragraph 2, the GDP rules described in Annex 4 apply mutatis mutandis. 4 The cantonal authorities must be notified of wholesale trade activities in accordan
Section 3 Licence for Trading in Foreign Countries
Art. 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 management and staff in the individual departments concerned take an active part in this system; b. a Responsible Person in accordance with Article 23 is available; c. the facilities are organised in an appropriate way; d. a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant procedures involved in the activities; e. due diligence is exercised as described in Article 22. 2 Swissmedic may specify further technical requirements and details. 3 The licence does not entitle the holder to issue manufacturing orders.
Art. 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 that supplier and customer are authorised to carry out the work procedures that they perform. They must be able to prove this. 3 They obtain in particular the documents showing the quality of the medicinal product and those showing at least the transaction date, quantity, batch number, expiry date and exact name of the medicinal product and the name and address of the supplier and customer, and keep these documents. 4 They ensure, including during transport, that the necessary storage conditions remain within the limits determined by the manufacturer or stated on the packaging. They must be able to prove this in writing. 5 They must provide the customer on each delivery with details of the original manufacturer and the original batch number of the merchandise delivered. 6 They must forward to
Art. 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 authorised to issue instructions within their sphere of activity. 3 They ensure their deputisation by adequately qualified specialists. 4 If the facilities cease operations, or if operations can be expected to cease imminently, they must report this situation to Swissmedic without delay. 5 They must have the necessary training, expertise and experience, and be trustworthy. 6 They decide independently of the company’s management and may not sit on any of the facilities’ supervisory committees. Swissmedic may grant a licence to small facilities without such segregation if they cannot implement the segregation because of their size. 7 If the size and nature of the facilities permit this activity to be performed on a part-time basis, responsibilities must be specified in writing and the minimum number of hours that the Responsible P
Section 4 Licence to perform Brokerage or Agency A
Art. 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 staff in the individual departments concerned take an active part in this system; b. a Responsible Person in accordance with Article 26 is available; c. the facilities are organised in an appropriate way; d. a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant procedures; e. due diligence is exercised as described in Article 25. 2 Swissmedic may specify further technical requirements and details. 3 The licence does not entitle the holder to issue manufacturing orders.
Art. 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. 2 They must ensure that the medicinal products have not originated from illegal trading and are not intended for unlawful purposes. 3 They must forward to the customer or the supplier all information provided by any supplier or customer regarding the quality and safety of the medicinal product or that is relevant for the authorities, in particular information about medicinal product recalls. 4 The agents must additionally retain copies of the paperwork documenting the business transaction.
Art. 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 They are authorised to issue instructions within their sphere of activity. 3 They ensure their deputisation by adequately qualified specialists. 4 If the facility ceases operations, or if operations can be expected to cease imminently, they must report this situation to Swissmedic without delay. 5 They must have the necessary training, expertise and experience, and be trustworthy. 6 They decide independently of the company’s management and may not sit on any of the facilities’ supervisory committees. Swissmedic may grant a licence to small facilities without such segregation if they cannot implement the segregation because of their size. 7 If the size and nature of the facilities permit this activity to be performed on a part-time basis, responsibilities must be specified in writing and the minimum number of hours during whic
Section 5 Special Provisions for Blood and Blood P
Art. 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 prove that: a. the conditions described in Article 3 have been fulfilled; b. the Responsible Person fulfils the conditions of Articles 5 and 6 and has a university degree in medicine or a life science and the scientific and medical experience needed to collect blood; c. blood is collected in compliance with the GMP rules described in Annex 1; d. due diligence is exercised as described in Articles 28–38. 2 Swissmedic may specify further technical requirements and details.
Art. 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 and have the appropriate technical knowledge. 3 This person has an obligation to report adverse drug reactions in accordance with Articles 61 and 65 TPO. 4 Swissmedic may also recognise persons with other professional qualifications as Responsible Persons, provided they possess sufficient knowledge and experience. 5 While Responsible Persons do not need to be employees of the company, their responsibilities must in all cases be defined in writing.
Para. 3 — SR 812.212.21
Art. 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 supervision of a qualified physician. 2 The donors must be provided with comprehensive information about donating blood and the risks of infection with major pathogens must be explained before the blood donation so that they can decide not to donate blood if the blood they donate could represent a risk of infection for third parties. 3 Otherwise, the information provided in the context of a donation is guided by Annex 5 number 3. 4 Persons in the following categories are not permitted to donate blood: a. those who have been diagnosed with HIV; b. those who are suffering from AIDS or who have symptoms indicative of an AIDS-related illness; c. those whose behaviour carries the risk of infection with HIV; d. intimate partners of persons described under letters a–c; e. those who carry a specific risk of prion
Art. 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. 2 The tests must be performed using appropriate methods or procedures that are validated in accordance with the state-of-the-art scientific and technical knowledge and are suitable for testing donated blood and plasma. 3 Before blood or erythrocyte preparations are transfused, their compatibility with the recipient's blood must be established using appropriate methods.
Art. 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 technical requirements and particulars in relation to the tests and test procedures. 3 When tests are being carried out on blood or labile blood products intended for transfusion or to manufacture medicinal products, the rules of good practice must be adhered to in accordance with Annex 1 of the Ordinance of 29 April 2015 on Microbiological Laboratories.
Para. 3 — SR 818.101.32
Art. 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 blood intended for autologous transfusion give a negative result or if the results of tests carried out in accordance with Annex 5, number 2.2 letter d deviate from the norm, the treating physician decides whether to carry out the transfusion.
Art. 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 offered counselling and assistance. 3 The donor may refuse to be informed of a test result.
Art. 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 on Microbiological Laboratories. 2 In the case of autologous transfusion, the label must also bear the name of the donor and the label must be signed by the autologous donor immediately before blood collection. 3 Autologous donations must be kept separate from homologous donations.
Para. 1 — SR 818.101.32
Art. 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 manufacture, release, distribution, destruction and recall of blood or labile blood products. 2 They must ensure that blood or labile blood products can be traced back to the donor. For this purpose, each blood donation must be given a donor number that makes it possible at any time to clearly identify the donation, the donor's medical history, every blood product made from his donation and all documents related to these products. 3 Whenever blood is donated, the following information must be recorded in detail: a. the date and identification of the donation and the donor; b. information on the decision on donor suitability and, if relevant, the reason for excluding a donor; c. the test results and their interpretation. 4 Each protocol must be signed by a person who is authorised to do so by the qualit
Art. 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 archives must be handed over to Swissmedic, or to the Blood Transfusion Service of the Swiss Red Cross if it is one of its establishments. 2 Swissmedic or the Blood Transfusion Service of the Swiss Red Cross destroys the archives on expiry of the archiving obligation.
Art. 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 fulfil the criteria required to be considered a suitable donor; b. the tests for transmittable diseases have not been carried out in accordance with the regulations; c. the donor has undergone seroconversion or has contracted a blood-borne infection; d. the recipient of a donation develops a post-transfusion infection which could be traced back to the donor; e. serious defects in relation to the GMP rules described in Annex 1 have occurred during the blood collection process or the manufacturing of labile blood products. 2 The measures that will be taken if the situations described in paragraph 1 letters b–e occur must be reported to Swissmedic. 3 Measures taken in the event of occurrences described in paragraph 1 letters c and d may involve investigations into previous donations or other donors. 4 Inst
Art. 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 Plasma may only be used for homologous transfusions if, in addition to the safety measure described in paragraph 1 and the tests described in Article 30: a. it has been stored for four months and on expiry of the deadline a new test on the donor produced a negative result; or b. it has undergone a procedure to inactivate or eliminate viruses. 3 Platelet concentrates may only be used in Switzerland if appropriate measures are taken to mitigate the risk of bacterial contamination. 4 Unused autologous donations must not be used for homologous transfusions or to manufacture blood products.