Regulation (EU) on clinical trials on medicinal products for human use

3202. Decree on the implementation of the Regulation (EU) on clinical trials on medicinal products for human use

Pursuant to Article 21(7) of the Government of the Republic of Slovenia Act (Official Gazette of the Republic of Slovenia, no. 24/05 - Official Consolidated Text, 109/08, 38/10 - ZUKN, 8/12, 21/13, 47/13 - ZDU-1G, 65/14 and 55/17), the Government of the Republic of Slovenia issues the following

DECREE

on the implementation of the Regulation (EU) on clinical trials on medicinal products for human use

I. GENERAL PROVISIONS

Article 1

(content)

This Decree establishes the competent authorities, the national contact point, the national procedures relating to clinical trials on medicinal products for human use (hereinafter: Clinical Trials) and sanctions for the implementation of Regulation (EU) no. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (OJ L no. 158 of 27 May 2014, p. 1), as last amended by Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) no. 536/2014 of the European Parliament and of the Council by laying down principles and guidelines of good manufacturing practice on clinical trials on medicinal products for human use and regulating the conduct of reviews (OJ L no. 238 of 16 September 2017, p. 12), (hereinafter: Regulation 536/2014/EU), Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 laying down detailed arrangements for the procedures for good clinical practice inspections under Regulation (EU) 536/2014 of the European Parliament and of the Council (OJ L no. 80 of 25 March 2017, p. 7; hereinafter Regulation 2017/556/EU), Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) no. 536/2014 of the European Parliament and of the Council as regards the establishment of rules and procedures for the cooperation of Member States in the safety assessment of clinical trials (OJ L no. 5 of 10 January 2022, p. 14; hereinafter: Regulation 2022/20/EU), and the present Decree.

Article 2

(competent authorities)

(1) The competent authority for the implementation of Regulation 536/2014/EU, Regulation 2017/556/EU, Regulation 2022/20/EU, and this Decree shall be the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter referred to as: JAZMP).

(2) The competent authority for the performance of the tasks of the ethics committee in accordance with Regulation 536/2014/EU and this Decree shall be the Medical Ethics Committee of the Republic of Slovenia (hereinafter referred to as: KME RS).

Article 3

(national contact point)

The national contact point referred to in Article 83 of Regulation (EU) 536/2014/EU shall be the JAZMP.

Article 5

(investigator)

(1) One principal investigator shall be designated at the clinical trial site.

(2) The principal investigator shall be a licensed medical doctor or a licensed doctor of dental medicine who is qualified to conduct clinical trials in accordance with the principles of good clinical practice.

II. AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL

Article 6

(validation of the application - validation)

The validation of the completeness of an application for the approval of a clinical trial and of an application for a substantial modification of a clinical trial (hereinafter: application) shall be carried out by the JAZMP.

Article 7

(evaluation of the application)

(1) The JAZMP shall carry out a scientific review of the clinical trial and the substantial modification of the clinical trial and shall prepare part I of the assessment report as referred to in Articles 6, 11, 18 and 22 of Regulation 536/2014/EU.

(2) The KME RS shall carry out an ethical review of the clinical trial and the substantial modification of the clinical trial and shall prepare part II of the assessment report as referred to in Articles 7, 11, 20 and 22 of Regulation 536/2014/EU.

(3) If the KME RS has concerns regarding the ethicality of the conduct of the clinical trial covered by part I of the assessment report referred to in paragraph 1 of this Article, it shall, within 30 days of the date of validation of the relevant application, inform the JAZMP, which prepared the assessment report referred to in paragraph 1 of this Article.

Article 8

(decision)

(1) The JAZMP shall notify the sponsor of the decision on approval, conditional approval, or refusal of the clinical trial or on the substantial modification of the clinical trial.

(2) If the KME RS fails to submit part II of the assessment report referred to in Articles 7, 11, 20 and 22 of Regulation 536/2014/EU with the conclusion within the timelines laid down in Regulation 536/2014/EU and in this Decree and fails to communicate the concerns referred to in the third paragraph of the preceding Article, its decision regarding the application shall be construed as its findings regarding aspects of part I of the assessment report referred to in Articles 6, 11, 18 and 22 of Regulation 536/2014/EU and, in the case of a substantial modification of an aspect of part II of the assessment report referred to in Articles 7, 11, 20 and 22 of Regulation 536/2014/EU, the substantial modification shall be deemed approved. In such cases, the JAZMP shall notify the sponsor of the decision without the opinion of the KME RS.

III. CONFLICT OF INTEREST AND LANGUAGE OF THE APPLICATION

Article 9

(conflict of interest)

(1) Persons validating completeness and assessing the documentation for a human clinical trial shall have no conflict of interest and shall be independent of the sponsor, of the clinical trial site and the investigators involved in the clinical trial and of persons financing the clinical trial, as well as free of any other undue influence.

(2) The persons referred to in the preceding paragraph shall sign a declaration of independence and absence of conflict of interest stating that they have no conflict of interest or appearance of conflict of interest, that they are independent of the sponsor, the clinical trial site, the investigators involved in the clinical trial and the persons financing the clinical trial, and are otherwise impartial, and that they have no financial or personal interests which may affect their impartiality.

(3) The persons referred to in the first paragraph of this Article shall, if circumstances arise which would be inconsistent with the declaration referred to in the preceding paragraph, immediately cease to act as an evaluator and shall inform the JAZMP or the Chairman of the KME RS within three working days of such circumstances of conflict of interest arising or becoming known to them.

(4) A pharmaceutical inspector shall make the declaration referred to in paragraph 2 of this Article once a year for the purposes of compliance with the requirements laid down in Article 5 of Regulation 2017/556/EU.

Article 10

(language)

(1) The documentation of an application for approval of a clinical trial and an application for approval of a substantial modification of a clinical trial shall be in Slovenian or English language.

(2) Notwithstanding the preceding paragraph, the cover letter, the protocol summary, and the documentation intended for the participants shall be in Slovenian.

(3) The protocol summary referred to in the preceding paragraph shall contain a brief description of:

1. the purpose and scientific significance of the clinical trial, supported by references to the relevant literature, including Slovenian literature,

2. the planned methods, including statistical methods,

3. the intended duration of the clinical trial,

4. the intended number and age of participants in the clinical trial,

5. the procedures for inclusion of participants,

6. the criteria for inclusion and exclusion, including criteria for withdrawal of individual subjects from treatment or the clinical trial,

7. any potential randomisation,

8. ethical considerations related to the clinical trial, benefits, risks, and burdens for the participants.

(4) The content of the summary of the results of the clinical trial for laypersons shall be in the Slovenian language.

(5) Investigational and auxiliary medicinal products shall be labelled in Slovenian or English language.

(6) Notwithstanding the previous paragraph, investigational medicinal products and auxiliary medicinal products received by participants for home use shall be labelled in Slovenian language.

IV. REPORTING OF UNEXPECTED SERIOUS ADVERSE REACTIONS

Article 11

(reporting of suspected unexpected serious adverse reactions)

(1) After acquiring prior agreement of the JAZMP, a non-commercial sponsor may, due to a lack of resources, exceptionally notify the JAZMP on a suspected unexpected serious adverse reactions occurring in the territory of the Republic of Slovenia, using the form for reporting adverse reactions of medicinal products published on the JAZMP website instead of entering information on the suspected adverse reactions into the database referred to in Article 40(1) of Regulation 536/2014/EU.

(2) The agreement of the JAZMP referred to in the preceding paragraph shall be acquired by the non-commercial sponsor prior to the commencement of a clinical trial based on an appropriate justification stated in the cover letter.

Article 12

(assessment of safety reports)

Information referred to in Articles 42 and 43 of Regulation 536/2014/EU shall be assessed by the JAZMP. The KME RS shall be granted access to data on the assessment reports of suspected serious adverse reactions and annual safety reports upon prior request.

V. SPECIFIC REQUIREMENTS FOR INVESTIGATIONAL MEDICINAL PRODUCTS

Article 13

(specific requirements for the manufacturing and preparation of investigational medicinal products)

(1) The procedures referred to in Article 61(5) of Regulation 536/2014/EU shall be carried out and supervised in accordance with the law regulating the pharmacy activity and implementing regulations issued pursuant thereto.

(2) Documentation referred to in Item 35 of Annex I to Regulation 536/2014/EU for:

1. the re-labelling and re-packaging of investigational medicinal products in hospitals, clinics and clinical institutes shall comprise:

- a valid authorisation for undertaking pharmacy activities involving the supply of medicinal products for clinical trials; and

- a good clinical practice certificate for pharmacists involved in the conduct of the clinical trial.

2. the re-labelling and re-packaging of investigational medicinal products in health centres and outpatient clinics shall comprise:

- a valid agreement or other written agreement of cooperation with the pharmacy services provider;

- valid authorisation from the pharmacy services provider for carrying out pharmacy activities involving the supply of medicinal products for clinical trials; and

- a good clinical practice certificate for pharmacists involved in the conduct of the clinical trial.

3. the preparation of radiopharmaceuticals used as diagnostic investigational medicinal products, shall comprise:

- authorisation for carrying out radiopharmaceutical pharmacy activities; and

- a good clinical practice certificate for pharmacists involved in the conduct of the clinical trial.

4. the preparation of medicinal products referred to in Item (c) of the fifth paragraph of Article 61 of Regulation 536/2014/EU shall comprise:

- a valid authorisation for undertaking pharmacy activities involving the supply of medicinal products for clinical trials;

- a good clinical practice certificate for pharmacists involved in the conduct of the clinical trial; and

- evidence that an inspection as per the third paragraph of this Article has been carried out within the last three years, including an examination of the procedures for the preparation of medicinal products referred to in Item (c) of the fifth paragraph of Article 61 of Regulation 536/2014/EU. If the pharmacy services provider does not have such evidence, an inspection shall be carried out before the approval of the clinical trial. Costs of the inspection procedure shall be borne by the clinical trial applicant.

(3) In the case of operators of the procedures referred to in Article 61(5) of Regulation 536/2014/EU, supervision of clinical trials of medicinal products shall be carried out by the pharmaceutical inspectors of the JAZMP in accordance with Regulation 2017/556/EU.

VI. INSURANCE AGAINST DAMAGES

Article 14

(insurance against damages)

Before the commencement of a clinical trial, insurance or a guarantee shall be provided to cover the liability of the sponsor and the liability of the investigator for any potential damage suffered by a participant as a result of participation in a clinical trial conducted in the territory of the Republic of Slovenia.

VII. FEES

Article 15

(fees)

(1) For the costs of the procedures and activities of the JAZMP and the KME RS in accordance with Regulation 536/2014/EU and this Decree, the sponsor shall pay a fee to the JAZMP. JAZMP shall within 60 days of payment of the sponsor's fee transfer the funds for the part of the fee of KME RS in accordance with the Tariff of the JAZMP to the budget of the Republic of Slovenia, to account no. 01100-1000621284, reference 18 27111-4029399-18009422 (payments from abroad to account no. 01100-1000621284, SWIFT BSLJSI2X, IBAN SI56 01100-1000621284, delivery account 18 27111-4029399-18009422). The Ministry of Health will earmark the funds so received for payment of the operating expenses of KME RS.

(2) The type of fee, the amount, and the detailed method of payment of the fees are laid down in the Tariff of the JAZMP.

VIII. SUPERVISION

Article 16

(supervision)

(1) Inspection and infringement supervision of the implementation of Regulation 536/2014/EU and this Decree shall be carried out by the pharmaceutical inspectors of the JAZMP (hereinafter: pharmaceutical inspectors).

(2) Inspection and infringement supervision regarding the protection of personal data referred to under Item (d) of Article 28(1) of Regulation 536/2014/EU shall be carried out by the Information Commissioner in accordance with regulations on the protection of personal data.

(3) At the request of inspectors from other Member States of the European Union the JAZMP shall enable access to the site, premises and data related to the clinical trial.

(4) On the basis of cooperation among Member States, a request from a competent authority of a Member State, the European Medicines Agency or the European Commission, a request from a competent authority or a commercial entity from the European Union or a third country, pharmaceutical inspectors shall, in accordance with Regulation 536/2014/EU and in accordance with the European Union's Compendium of Procedures, carry out professional tasks of verifying compliance with good clinical practice at a commercial entity abroad.

IX. PENAL PROVISIONS

Article 17

(offences of the sponsor)

(1) A legal entity shall be liable to a fine of between 800 and 180,000 EUR if it, as a sponsor:

1. conducts a clinical trial without a decision on the approval of the clinical trial or conditional approval of the clinical trial as referred to in Article 8(1) or Article 14(3) of Regulation 536/2014/EU,

2. conducts a clinical trial that has been substantially modified without a decision to grant a substantial modification of a clinical trial or to grant a conditional approval of a substantial modification of a clinical trial as referred to in Article 19(1), Article 20(5), or Article 23(1) of Regulation 536/2014/EU,

3. conducts a clinical trial in breach of item (a) of Article 28(1) of Regulation 536/2014/EU,

4. fails to ensure that subjects or their legally appointed representatives give informed consent in accordance with Article 29(1) of Regulation 536/2014/EU, as provided by item (c) of Article 28(1) of Regulation 536/2014/EU,

5. fails to protect the rights of participants to physical and mental integrity and privacy, as provided for in item (d) of Article 28(1) of Regulation 536/2014/EU,

6. conducts a clinical trial in breach of items (e), (f) or (g) of Article 28(1) of Regulation 536/2014/EU,

7. fails to ensure that subjects are not improperly induced to participate in the clinical trial, including in financial terms, as provided for in item (h) of Article 28(1) of Regulation 536/2014/EU,

8. acts in breach of Article 28(3) of Regulation 536/2014/EU,

9. fails to ensure compliance with Article 31 of Regulation 536/2014/EU when enrolling incapacitated subjects in a clinical trial,

10. fails to ensure compliance with Article 32 of Regulation 536/2014/EU when enrolling minors in a clinical trial,

11. fails to ensure compliance with Article 33 of Regulation 536/2014/EU when enrolling pregnant or breastfeeding women in a clinical trial,

12. fails to ensure compliance with Article 35 of Regulation 536/2014/EU in emergency situations in clinical trials,

13. fails to notify the JAZMP of the start of a clinical trial, the first visit of the first participant or the completion of the recruitment of participants in the Republic of Slovenia in accordance with Article 36 of Regulation 536/2014/EU,

14. fails to notify the JAZMP of the end of a clinical trial in the Republic of Slovenia or the end of a clinical trial in all Member states concerned and all third countries in accordance with the first, second or third paragraph of Article 37 of Regulation 536/2014/EU,

15. fails to submit to the EU database a summary of the results of the clinical trial or a summary of the results of an interim data analysis in accordance with the fourth and eighth paragraphs of Article 37 of Regulation 536/2014/EU,

16. fails to notify the JAZMP of a temporary halt of a clinical trial in all Member states concerned or of a restart of a temporarily halted clinical trial in accordance with the fifth or sixth paragraph of Article 37 of Regulation 536/2014/EU,

17. fails to notify the JAZMP of the reasons for an early termination of a clinical trial for reasons that do not affect the benefit-risk balance, and of measures to be taken for participants in accordance with Article 37(7) of Regulation 536/2014/EU,

18. fails to notify the JAZMP of a temporary halt or early termination of a clinical trial due to a change in the benefit-risk balance in accordance with Article 38 of Regulation 536/2014/EU,

19. fails to keep a record of all adverse events reported by the investigator in accordance with Article 41(3) of Regulation 536/2014/EU,

20. fails to report suspected unexpected serious adverse reactions to the European Medicines Agency in accordance with Article 42 of Regulation 536/2014/EU,

21. fails to submit an annual safety report for each individual investigational medicinal product used in a clinical trial which it is sponsoring, in accordance with Article 43 of Regulation 536/2014/EU,

22. conducts a clinical trial in breach of Article 47 of Regulation 536/2014/EU,

23. fails to monitor a clinical trial in accordance with Article 48 of Regulation 536/2014/EU,

24. conducts a clinical trial in breach of Article 51 of Regulation 536/2014/EU,

25. fails to notify the JAZMP of a serious breach of Regulation 536/2014/EU or of the protocol in accordance with Article 52 of Regulation 536/2014/EU,

26. fails to notify the JAZMP of unexpected events in accordance with Article 53(1) of Regulation 536/2014/EU,

27. fails to submit to the JAZMP all reports on the inspection of the clinical trial by third country authorities in accordance with Article 53(2) of Regulation 536/2014/EU,

28. fails to take appropriate urgent safety measures to protect participants or fails to notify them to the JAZMP in accordance with the first and second paragraph of Article 54 of Regulation 536/2014/EU,

29. fails to review, update, or provide the investigator with the investigator brochure in accordance with Article 55 of Regulation 536/2014/EU,

30. fails to record, process, handle, or store clinical trial information in accordance with Article 56 of Regulation 536/2014/EU,

31. fails to prepare the clinical trial master file or enable JAZMP the access to it in accordance with Article 57 of Regulation 536/2014/EU,

32. fails to archive the clinical trial master file in accordance with Article 58 of Regulation 536/2014/EU,

33. conducts a clinical trial with investigational medicinal products that are not manufactured or imported in accordance with Articles 61, 62, 63 of Regulation 536/2014/EU or in accordance with Article 13 of this Decree,

34. fails to ensure that investigational medicinal products and auxiliary medicinal products are labelled in accordance with Articles 66 and 67 of Regulation 536/2014/EU and in accordance with Article 10 of this Decree,

35. fails to conclude a written agreement in accordance with Article 71 of Regulation 536/2014/EU for the delegation of tasks to an individual, company, institution, or organisation,

36. does not conduct a clinical trial with co-sponsors in accordance with Article 72 of Regulation 536/2014/EU,

37. conducts clinical trials with gene therapy that would result in genome alterations in the germline of the subject, contrary to Article 90(2) of Regulation 536/2014/EU,

38. does not have insurance or a guarantee in place for damages suffered by a clinical trial participant in accordance with Article 14 of this Decree,

39. requires participants to cover costs referred to in Article 92 of Regulation 536/2014/EU.

(2) A fine of 500 to 120,000 EUR shall be imposed on an individual sole trader or a self-employed individual who commits an offence referred to in the preceding paragraph.

(3) A fine of 300 to 10,000 EUR shall be imposed on the responsible person of a legal entity, the responsible person of a sole trader or the responsible person of a self-employed individual who commits the offence referred to in paragraph 1 of this Article.

(4) A fine of 150 to 5,000 EUR shall be imposed on an individual committing an offence referred to in paragraph 1 of this Article.

Article 18

(investigator offences)

A fine of 1,500 to 5,000 EUR shall be imposed on an individual if he/she as an investigator:

3. conducts a clinical trial in breach of item (a) of Article 28(1) of Regulation 536/2014/EU,

4. fails to provide information to clinical trial participants or their legally appointed representatives in accordance with Article 29(2) through (6) of Regulation 536/2014/EU, as provided for in item (b) of the first paragraph of Article 28 of Regulation 536/2014/EU,

5. fails to obtain informed consent from participants or their legally appointed representatives in accordance with Article 29(1) of Regulation 536/2014/EU, as provided for in item (c) of the first paragraph of Article 28 of Regulation 536/2014/EU,

6. fails to protect the rights of participants to physical and mental integrity and privacy, as provided for in item (d) of Article 28(1) of Regulation 536/2014/EU,

7. conducts a clinical trial in breach of items (f) or (g) of Article 28(1) of Regulation 536/2014/EU,

8. improperly induces subjects to participate in a clinical trial (item (h) of Article 28(1) of Regulation 536/2014/EU),

9. acts in breach of Article 28(3) of Regulation 536/2014/EU,

10. acts in breach of Article 31 of Regulation 536/2014/EU when enrolling incapacitated subjects in clinical trial,

11. acts in breach of Article 32 of Regulation 536/2014/EU when enrolling minors in a clinical trial,

12. acts in breach of Article 33 of Regulation 536/2014/EU when enrolling pregnant or breastfeeding women in a clinical trial,

13. does not conduct a clinical trial in emergency situations in accordance with Article 35 of Regulation 536/2014/EU,

14. fails to record, document, or report adverse events or laboratory abnormalities to the sponsor in accordance with Article 41(1) of Regulation 536/2014/EU,

15. fails to record and document all adverse reactions or report all serious adverse reactions to the sponsor in accordance with the second and fourth paragraphs of Article 41 of Regulation 536/2014/EU,

16. conducts a clinical trial in breach of Article 47 of Regulation 536/2014/EU,

17. does not fulfil the conditions for an investigator in accordance with Article 49 of Regulation 536/2014/EU,

18. conducts a clinical trial in breach of Article 51 of Regulation 536/2014/EU,

19. fails to take appropriate urgent safety measures to protect participants in accordance with Article 54(1) of Regulation 536/2014/EU,

20. fails to record, process, handle, or store clinical trial information in accordance with Article 56 of Regulation 536/2014/EU,

21. fails to prepare the clinical trial master file or enable JAZMP the access to it in accordance with Article 57 of Regulation 536/2014/EU,

22. fails to archive the clinical trial master file in accordance with Article 58 of Regulation 536/2014/EU,

23. fails to act as principal investigator in accordance with Article 73 of Regulation 536/2014/EU,

24. conducts clinical trials with gene therapy that would result in genome alterations in the germline of the subject, contrary to Article 90(2) of Regulation 536/2014/EU,

25. requires participants to pay the costs of investigational medicinal products or procedures specifically required by the protocol in breach of Article 92 of Regulation 536/2014/EU,

26. does not have insurance or a guarantee in place for damages suffered by a clinical trial participant in accordance with Article 14 of this Decree.

Article 19

(offences related to the conditions for the conduct of a clinical trial)

(1) A fine of 4,000 to 40,000 EUR shall be imposed for an offence on a legal entity that fails to ensure appropriate conditions for the conduct of a clinical trial in accordance with the declaration and description of the premises, equipment, human resources, and expertise referred to in item 67 of Annex I to Regulation 536/2014/EU.

(2) A fine of 3,000 to 30,000 EUR shall be imposed on an individual sole trader or a self-employed individual who commits an offence referred to in the preceding paragraph.

(3) A fine of 600 to 6,000 EUR shall be imposed on the responsible person of a legal entity, the responsible person of a sole trader or the responsible person of a self-employed individual who commits the offence referred to in paragraph 1 of this Article.

Article 20

(authorisation to impose a fine within the specified limits)

A fine for offences referred to in this Decree may also be imposed in expedited procedure in an amount higher than the minimum fine prescribed by this Decree.

X. TRANSITIONAL AND FINAL PROVISIONS

Article 21

(transitional period)

(1) Applications for approval or notification of a clinical trial of medicinal products and applications for notification of substantial modifications to a clinical trial of medicinal products submitted before 31 January 2022 shall be processed in accordance with the Medicinal Products Act (Official Gazette of RS, no. 17/14 and 66/19) and the Rules on Clinical Testing of Medicinal Products (Official Gazette of RS, no. 54/06 and 17/14 - ZZdr-2).

(2) Until 31 January 2023, applications for approval of clinical trials of medicinal products may be submitted and processed in accordance with Regulation 536/2014/EU and this Decree or in accordance with the Medicinal Products Act (Official Gazette of RS, no. 17/14 and 66/19) and the Rules on Clinical Testing of Medicinal Products (Official Gazette of RS, no. 54/06 and 17/14 - ZZdr-2).

(3) Clinical trials of medicinal products approved in accordance with the Medicinal Products Act (Official Gazette of RS, no. 17/14 and 66/19) and the Rules on Clinical Testing of Medicinal Products (Official Gazette of RS, no. 54/06 and 17/14 - ZZdr-2), which are still ongoing, shall be harmonised with Regulation 536/2014/EU and this Decree by 31 January 2025.

Article 22

(fees)

The Council of the JAZMP shall harmonise the Tariff of the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (Official Gazette of RS, no. 209/21) within 30 days of the entry of this Decree into force.

Article 23

(Effective date)

This Decree shall enter into force on the fifteenth day following its publication in the Official Gazette of the Republic of Slovenia.

no. 00704-359/2022

Ljubljana, 13 October 2022

EVA 2019-2711-0032

Government of the Republic of Slovenia

Dr. Robert Golob

President

Regulation (EU) on clinical trials on medicinal products for human use

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