Act No. 262 / 2019 Coll.

Act amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Laws

Valid Effective from 01.12.2019
262
THE LAW
of 24 September 2019
amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and other Related Acts
Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

Amendment to the Drug Act
Čl. I
Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act on Medicines), as amended by Act No. 124 / 2008 Coll., Act No. 296 / 2008 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 75 / 2011 Coll., Act No. 375 / 2011 Coll., Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 250 / 2014 Coll., Act No. 251 / 2017 Coll., Act No. 36 / 2018 Coll., Act No. 44 / 2019 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 251 / 2017 Coll., Act No. 36 / 2018 Coll., and Act No. 44 / 2019 Coll., is amended as follows:
1. In Article 3a (2), the words "or dental practitioner (hereinafter referred to as" doctor ") 'shall be inserted after the words" physician'.
2. in Paragraph 5 (9), the words "points 2 to 7 and 10 'are replaced by the words" points 2 to 6 and 9';
3. in Article 13 (2), point (m) is deleted;
Points (n) to (q) shall be renumbered as points (m) to (p).
4. in Paragraph 13 (3) (n):
"(n) establish and operate an electronic recipe information system (hereinafter referred to as the eRecept system);"
5. In Article 13, the following paragraph 4 is added:
"(4) The Institute provides data relating to the certificates it issues pursuant to § 81a (1)
(a) other organisations within the Ministry of Health's competence, in order to use certificates, to provide health services for access to, manage or provide information systems and services which such organisations establish;
(b) the Czech Social Security Administration for the purpose of verifying the identity of nursing doctors under the law governing sickness insurance. "
6. In Paragraph 19b, at the end of paragraph 1, the dot is replaced by a comma and the following point (g) is added:
"(g) the numbers and types of electronically readable identification documents.";
7. In Paragraph 19b, at the end of paragraph 2, the dot is replaced by a comma and the following points (i) and (j) are added:
"(i) in the case of minor children, the name and / or surname, surname, surname and maiden name and, where applicable, date of birth of the father and mother;
(j) the name and, where appropriate, the name, surname, surname and birth number or date of birth of the child. "
8. In the fourth sentence of Article 33 (2), the words "the price of the medicinal product which has a fixed public health insurance remuneration 'shall be inserted after the words" the medicinal product'.
9. in Article 33 (3) (g), the following point 4 is added:
"4. supply every distributor who makes a written declaration against the marketing authorisation holder that he requires medicinal products for the care of patients in the Czech Republic under § 77 (1) (h), medicinal products at a quantity and time intervals so that the distributor has medicinal products at least equivalent to the average demand of operators authorised to supply medicinal products for that distributor for 2 weeks. The marketing authorisation holder shall not be obliged to:
(a) the distributor has at least one cash debt to the marketing authorisation holder for more than 30 days after maturity;
(b) the distributor has been fined for the supply of the medicinal product to another Member State or third country in the last 2 years prior to the order, in breach of Article 77 (1) (h), which has already acquired legal authority,
(c) the marketing of the medicinal product in the Czech Republic is interrupted or terminated. "
10. in Paragraph 77 (1) (c) (4), "(f)" is replaced by "(e)."
11. in Paragraph 77 (1) (f):
"(f) ensure, when supplying authorised medicinal products, the registration of such products by means of their codes and deposit such records for a period of 5 years; the distributor regularly provides the Institute with complete and correct information on the volume of medicinal products that it has distributed to pharmacies and other health service providers, other distributors, dealers of reserved medicinal products and veterinary medicinal products, providing in particular information on the volume of medicinal products obtained pursuant to § 33 (3) (g) (4) and distributed under § 77 (1) (h) and the volume of advertising samples it has supplied to marketing authorisation holders or sales agents and the Veterinary Institute with complete and correct information on the volume of medicinal products that it has distributed to pharmacies, veterinary surgeons, breeders and manufacturers of medicated feed; the data provided shall include the identification of the distributor, the identification of the distributed medicinal product and the identification of the person to whom the medicinal product has been distributed, and, in the case of a medicinal product for human use with a defined public health insurance remuneration, an indication of its price; the structure of the data, form, manner and time interval of their provision by electronic reporting shall be laid down in implementing legislation; ';
12. in Paragraph 77 (1) (h):
"(h) to ensure the supply of medicinal products for human use to operators authorised to supply medicinal products at levels and intervals corresponding to the needs of patients in the Czech Republic. A distributor who has requested the delivery of medicinal products and has made a written declaration against the marketing authorisation holder in accordance with § 33 (3) (g) (4) shall be obliged to supply the medicinal products thus obtained only to operators authorised to supply medicinal products within 2 working days of receiving the requirement for the supply of medicinal products. The distributor may not distribute medicinal products obtained under § 33 (3) (g) (4). Where the pharmacy operator has at least one cash debt to the distributor for more than 30 days after the due date, the delivery condition is that the price of the medicinal product will be paid at the latest at the time of taking over by the pharmacy operator. The distributor shall not be required under this paragraph if the marketing of the medicinal product in the Czech Republic is interrupted or terminated, '.
13. in Article 79a (1), the words "and only on the electronic recipe" shall be inserted after the word "prescribe."
14. in § 79a (3), first and second sentences, "§ 81a" is replaced by "§ 81c."
15. in the third sentence of Article 79a (3), "§ 81a;" is replaced by "§ 81c;" and "§ 81a (1) (a) and (b)" is replaced by "§ 81 (4) (a) to (c) and § 81c (4) (a)";
16. In Paragraph 79a, the following paragraph 4 is added:
"(4) A physician prescribing an individually prepared cannabis-containing medicinal product for therapeutic use is required to provide the Institute with regular information on the results of treatment of individual patients in an anonymous form. The details, structure, form, manner and time interval of information shall be laid down in the implementing legislation. ';
17. Paragraph 80, including the title, reads:
„§ 80
Prescription of medicinal products in the provision of health services
(1) Medicinal products for the provision of health services are prescribed by medical practitioners.
(a) a recipe for a particular patient produced in electronic form (the "electronic recipe"),
(b) a recipe for a particular patient exposed in paper form in accordance with § 81f,
(c) a recipe with a blue stripe for a particular patient exposed in paper form in accordance with the law on addictive medicinal products containing narcotic drugs or psychotropic substances;
(d) a request for medicines, including transfusion products, for use in the provision of health services; or
(e) a request with a blue stripe displayed in paper form in accordance with the law on addictive substances for medicinal products containing narcotic or psychotropic substances for use in the provision of health services.
(2) The electronic recipe is created, modified or cancelled in the eRecept system at the request of the prescribing physician, which contains the information needed to create, modify or cancel the electronic recipe. In addition, the requirement to create an electronic recipe shall always include information on the patient's choice of means of transmission of the identification mark by which the electronic recipe is marked (hereinafter referred to as the "electronic recipe identifier ').
(3) In the event that the prescribing physician's requirement to create an electronic recipe contains all the specified data, the eRecept system shall create an electronic recipe and communicate to the prescribing physician, free of charge, the electronic recipe identifier to which the electronic recipe is marked. If the patient requests the sending of an electronic recipe identifier from eRecept directly, the system shall also communicate it to the patient free of charge.
(4) The electronic recipe identifier shall be transmitted to the patient free of charge; when transmitting an electronic recipe identifier, there shall be no advantage to a specific pharmacy provider or interference with the patient's right to choose a pharmacy provider. Unless the patient chooses otherwise, the electronic recipe identifier shall be transmitted by means of a paper form. The patient may choose to send an electronic recipe identifier free of charge in a manner other than that specified in the second sentence, which is:
(a) a data message sent to the address of the patient's e-mail using the service of the central repository of electronic recipes,
(b) a text message sent to the patient's mobile telephone device using the service of the central repository of electronic recipes;
(c) a data message using the eRecept web or mobile application made available by the Institute;
(d) a data message sent, by agreement with the prescribing physician, to the address of the patient's e-mail using the doctor's information system service; or
(e) a text message sent, by agreement with the prescribing physician, to the patient's mobile telephone device using the information system service of the prescribing doctor.
(5) The implementing act provides for:
(a) the procedure and conditions for communicating doctors and pharmacists with the eRecept system;
(b) the form of the electronic recipe identifier provided by eRecept to prescribers and patients;
(c) the way in which the requirements for the creation, modification and cancellation of the electronic recipe prescribed by doctors are sent,
(d) the extent of the information to be provided to the applicants, its period of validity and the rules governing its use;
(e) the scope of the information to be provided on the guide, its model and the rules for its use after delivery;
(f) the model of the blue stripe recipe and the model of the blue stripe request, the data on them, their period of validity and the rules for their use;
(g) the extent and duration of the data needed for the creation, modification and cancellation of the electronic recipe;
(h) the extent of the data given on the paper-based recipe and its duration; and
(i) rules on the use of the recipe in paper form.
(6) When prescribing medicinal products for human use, physicians are required to treat medicinal products in such a way as to avoid inappropriate or uneconomical treatment of medicinal products with regard to the nature of the disease and the duration of the intended treatment with the medicinal product.
(7) When prescribing medicinal products for human use, doctors are required to act in such a way as to avoid any advantage to a particular pharmacy provider or to interfere with the patient's right to choose a pharmacy provider. The electronic recipe identifier, irrespective of the mode of transmission, shall not be accompanied by any advertising communication. The disclosure of the advertising character and the elements which would restrict the legibility of the information provided by the doctor shall not give rise to the provision of a paper-based recipe. '
18. The following Section 80a is inserted after Section 80:
„§ 80a
Prescription of medicinal products for veterinary care
(1) Without prejudice to the provisions concerning the conditions for the prescription of veterinary autogenic vaccines and medicated feedingstuffs, veterinary medicinal products and medicinal products for human use shall be prescribed by the veterinary surgeon in their professional capacity solely for the purpose of providing veterinary prescription in paper form, namely:
(a) a recipe issued in paper form for an animal or group of animals in a clearly identified breeder; This recipe is not to be transferred into electronic form when dispensing the medicinal product,
(b) a recipe with a blue stripe displayed in paper form in accordance with the Act on addictive substances for an animal or group of animals in a clearly identified breeder for medicinal products containing narcotic drugs or psychotropic substances; This recipe is not to be transferred into electronic form when dispensing the medicinal product,
(c) a request for medicinal products for a clearly identified veterinarian for the use or supply of the medicinal product in the provision of veterinary care; or
(d) a blue stripe request for medicinal products containing narcotic or psychotropic substances for a clearly identified veterinarian for the use of the medicinal product or its supply when providing veterinary care.
(2) The veterinary surgeon may prescribe the medicinal product only for a defined clinical diagnosis or other reason for the need for the use of the medicinal product established in accordance with the terms of the marketing authorisation of the medicinal product concerned or in accordance with the current state of scientific knowledge, only:
(a) on the basis of a properly carried out and documented examination of the animal or animals;
(b) on the basis of a detailed and documented set of information on the health status of the animal or animals and any other conditions which may affect the safety or efficacy of the prescribed medicinal product in its subsequent use; or
(c) on the basis of an immediate assessment of the health status of the animal or other information to the extent necessary to decide on the use of the medicinal product in such a way as to minimise the risk of its adverse effects if there is an exceptional case of danger to the health or life of the animal.
(3) The implementing act provides for:
(a) the requirements of the recipe and the requisition, their period of validity, restrictions on the type and quantity of medicinal products for the treatment of animals that may be prescribed for them and the rules on their use; and
(b) the requirements of the blue stripe recipe and the blue stripe requisites, their period of validity, restrictions on the type and quantity of medicinal products for the treatment of animals prescribed therein and the rules for their use. ";
19. In Part One, Title IV, Part 3, the following Section 2 is inserted after Section 80a:

„Oddíl 2

The eRecept system '.
Sections 2 and 3 shall be renumbered Sections 3 and 4.
20. Sections 81 and 81a, including the headings and footnotes No 109 to 112, read:
„§ 81
ERecept system
(1) The Institute establishes eRecept as a public administration information system. The eRecept system consists of interconnected components, namely:
(a) the central repository of electronic recipes;
(b) a restricted register of medicinal products,
(c) consultation services for eRecept data in connection with prescription and dispensing of medicinal products for a particular patient (hereinafter referred to as "drug record"),
(d) a system of consent management with the possibility to consult the pharmaceutical record (hereinafter referred to as "consent management"),
(e) services recording and storing information on all activities carried out in the eRecept system (hereinafter referred to as "activity journal");
(f) web and mobile application services for doctors, pharmacists and patients; and
(g) services providing statistical data from an anonymous data database maintained in eRecept.
(2) The Institute is the administrator and operator of eRecept. Furthermore, the Institute accedes to the eRecept system by means of an authentication information system under another legislature109) for the purpose of fulfilling the obligations laid down by this Act or other legislation. The eRecept operating documentation creates and publishes the Institute on its website.
(3) The eRecept system provides free of charge
(a) the immediate communication of the electronic recipe identifier to the physician and, where appropriate, to the patient at his request;
(b) continuous access to the electronic recipe by the pharmacist for the prescription to be issued in the relevant pharmacy;
(c) continuous access by prescribers to the data referred to in Section 81c (2) relating to the patient to whom a restricted medicinal product is to be prescribed;
(d) continuous access to the data referred to in Section 81c (2) relating to a patient to whom a restricted medicinal product is to be prepared or issued;
(e) continuous access by a doctor to the electronic prescriptions through which he prescribed the medicinal product, as well as to the data displayed in the patient's pharmaceutical record under the conditions laid down in § 81d;
(f) continuous access for the pharmacist to the electronic recipes on the basis of which the medicinal product has been issued in the relevant pharmacy, as well as to the data displayed in the patient's pharmaceutical record under the conditions laid down in § 81d;
(g) access to patients' access to all electronic prescriptions through which the medicinal product has been prescribed, to data displayed in their drug record under § 81d, and to data relating to them in the eRecept system;
(h) access by the health insurance undertaking to the electronic recipes for which a public health insurance medicinal product has been issued to its insured persons;
(i) access by the Ministry of Health to the electronic recipes through which the medicinal product has been prescribed to the persons for whom the health services are covered by the State;
(j) access to the data contained in the restricted medicinal product register by the police of the Czech Republic;
(k) access of the Institute of Health Information and Statistics to the anonymized data database maintained in eRecept;
(l) a service for the transmission of data through the services of the National Contact Point for Electronic Healthcare under the Health Services Act 110 (hereinafter referred to as the National Contact Point) necessary to enable the issue of a medicinal product which has been electronically prescribed in the Czech Republic in another Member State;
m) a service for the transmission of data through the services of the National Contact Point necessary to enable the dispensing of a medicinal product, which was electronically prescribed in another Member State, in the Czech Republic.
(4) The Institute processes through the eRecept system
(a) the name and, where applicable, the name, surname and date of birth of the doctor and his contact details, including his telephone, laid down in the implementing legislation, and, in the case of medicinal products with restrictions, the specialisation of the prescribing physician, and the identification details of the health service provider in whose activities the doctor provides health services, to the extent of his name, address of the medical establishment and the workplace identification number, if assigned by the health insurance undertaking;
(b) the name and, where applicable, the name, surname and date of birth of the pharmacist and his contact details as provided for in the implementing legislation and the identification details of the health service provider authorised to supply medicinal products in the course of whose activity the pharmacist provides medical services, to the extent that the name of the pharmacist, the address and contact details of the pharmacy,
(c) patient identification data to the extent indicated in the prescription;
(d) particulars of the medicinal products prescribed and issued, including the name, quantity and code of the medicinal product, if assigned by the Institute.
(5) The eRecept system records in the activity journal every request sent and activity entered into it. The activity journal records eRecept access and activities of all entities authorised to enter eRecept.
(6) The Institute shall keep the information held in the central repository of electronic recipes and journal of activities, including the data referred to in paragraph 4, for a period of 5 years from the expiry of the electronic recipe or from the creation of an electronic record of the recipe issued in paper form in accordance with Section 81f. After this period, all information related to such an electronic recipe or an electronic record of the recipe in paper form shall be removed from eRecept. Information in the journal of activities which are not linked to a specific electronic recipe or to an electronic record of a recipe issued in paper form, the Institute shall keep for 5 years after their creation. After this period the information is removed from the eRecept system.
§ 81a
Access to eRecept system
(1) The eRecept system and its components are accessed by the physician and the pharmacist through the Institute of Access Data issued and the health service provider's access certificate, in the framework of which it provides health services. Furthermore, the eRecept system is accessed through the Institute of Issued Access Data by an authorised health insurance worker, an authorised health worker and an authorised worker of the Police of the Czech Republic. The procedure and conditions for obtaining access data and certificates shall be laid down in implementing legislation.
(2) The eRecept system is also approached by means of an authentication information system under another legislature109) The Institute, the Ministry of Health and the Institute of Health Information and Statistics for the purpose of carrying out statistical activities.
(3) The patient approaches the eRecept system using the National Identification and Authenticaci111 services). If the person in custody, prison sentence or security detention is involved, the information on the contents of their drug record referred to in Section 81d (3) shall be made available to them in paper form by the competent prison service physician.
(4) The public administration contact point (112) will, at the request of the patient, issue a certified eRecept output containing data relating to the patient to the extent provided for by the implementing legislation. The output according to the first sentence is the verified output of the public administration information system.
(5) The doctor and pharmacist communicate with eRecept directly or via the communication interface of this system and the information system used by the doctor or pharmacist.
(6) Information systems used by a doctor for prescription and pharmaceutical purposes for dispensing medicinal products must be fully compatible with eRecept and correspond to its technical documentation.
(7) Information that doctors and pharmacists have access to in eRecept through the information systems they use can only be used in the provision of health services. Other use of such data or making it available to third parties shall be prohibited.
(8) The eRecept system is not publicly available.
109) Act No. 111 / 2009 Coll., on Basic Registers, as amended.
110) Article 69a of the Health Services Act.
111) Act No. 250 / 2017 Coll., on Electronic Identification, as amended.
112) Act No. 365 / 2000 Coll., on Information Systems of Public Administration and on the amendment of certain other laws, as amended. '
21. The following Sections 81b to 81f are inserted after Section 81a, including the headings and footnotes Nos 113 to 116:
„§ 81b
The central repository of electronic recipes
(1) The central repository of electronic recipes is set up for security within the eRecept system
(a) collecting and storing electronic recipes;
(b) the collection and storage of records of the dispensation of medicinal products for an electronic prescription, including information on which medicinal product has actually been issued;
(c) the collection and storage of electronic records of recipes issued in paper form in accordance with Section 81f on the basis of which the dispensing of the medicinal product was carried out, including information on the actual release of the medicinal product;
(d) the collection and storage of information relating to the handling of the electronic recipe, including the states in which the electronic recipe is located.
(2) The implementing act lays down the scope of the data referred to in paragraph 1 (d).
§ 81c
Register of restricted medicinal products
(1) The restricted register of medicinal products ensures that the prescription and dispensation of the medicinal product is limited to the quantity and duration specified in the marketing authorisation pursuant to Article 39 (4) (c) or Article 39 (5) and the restriction laid down by the Public Health Insurance Act (113) or the implementing legislation for an individually prepared medicinal product containing cannabis for therapeutic use ("restricted medicinal products").
(2) The prescribing physician and the issuing pharmacist shall have access to the personal data of the patient in the medicinal product registry with a restriction in order to verify whether, in relation to this patient to whom such medicinal product is to be prescribed, prepared or issued, the conditions laid down in the marketing authorisation or in the implementing legislation are met.
(3) If the conditions for delivery of a medicinal product with a restriction are met, the issuing pharmacist shall issue the medicinal product with a record of the delivery of the medicinal product without delay in the register of medicinal products with a restriction.
(4) The Institute further via eRecept as administrator of the Restricted Medicines Register
(a) process data on prescribed and issued medicinal products with restrictions, including names, quantities, selling prices and the product code, where assigned by the Institute;
(b) keep the particulars referred to in Article 81 (4) (a) to (c) after the issue has been made, for the period for which the quantitative restriction on the medicinal product is provided for
1. in a marketing authorisation pursuant to § 39 (4) (c) or § 39 (5) for authorised medicinal products; or
2. in the implementing legislation referred to in Section 79a (1) for individually prepared medicinal products containing cannabis for therapeutic use; where no expenditure has been made, the period from the date of verification shall be calculated as to whether the conditions for preparation are met.
§ 81d
Pharmaceutical record
(1) The pharmaceutical record allows the patient, doctor, pharmacist and clinical pharmacist to be consulted on the data on medicinal products prescribed and issued to a particular patient contained in the central repository of electronic recipes, including further processing.
(2) If a doctor or a clinical pharmacist wishes to consult the patient's drug record for the first time, the patient's drug record shall be made available to the doctor and the clinical pharmacist only after proof of the patient's identity with the health service provider; This condition may not be met for doctors and clinical pharmacists with a provider already prescribed an electronic prescription for the patient in the framework of the provision of the health service and at least one package of the medicinal product has been issued to the patient. The patient's identity is demonstrated through the eRecept system by verifying the ID number or passport in the population base register.
(3) The patient's drug record allows you to view the central repository of electronic recipes
(a) information on prescribed medicinal products;
(b) information on medicinal products issued;
(c) the identification of the doctor and the health service provider in whose activity the doctor has prescribed the medicinal product to the patient, to the extent that the name or names, and the surname and contact details of the doctor, including his telephone, the name of the health service provider, the address of the medical institution and the workplace identification number, have been assigned by the health insurance company; and
(d) the identification data of the pharmacist and the pharmacist in whose activity the pharmacist issued the prescribed medicinal product to the patient, to the extent of the name and / or the name of the issuing pharmacist, the name of the pharmacist, the address and contact details of the pharmacy in which the medicinal product was issued.
(4) The patient may, by means of a pharmaceutical record, refer to the data referred to in paragraph 3 relating to him and to the journal of activities, in particular to data on the time and type of operation and the identification of the agent of the operation related to the data relating to his or her person.
(5) Under the conditions laid down in § 81e, a physician may only refer to the patient's data through his medical record in connection with the provision of health services to that patient, such as:
(a) a doctor of a registered health service provider;
(b) another treating physician when providing health services; or
(c) a physician in the context of emergency care intervention.
(6) A clinical pharmacist may, under the conditions laid down in § 81e, only view the patient's data through his drug record in the course of his activities with a health service provider in connection with the provision of health services by that provider to that patient.
(7) A pharmacist may, under the conditions laid down in Section 81e, only view data through the patient 's drug record in connection with the provision of health services to that patient,
(a) when dispensing medicinal products on the basis of an identifier of a valid electronic recipe for which all prescribed medicinal products have not yet been issued; or
(b) after the identification number of the identity card or passport has been entered in the context of a personal consultation with the patient who submits this identity document to the pharmacist.
(8) The eRecept system will allow a physician to view the patient's data from paragraphs 5 to 7 for a period of 5 years and a pharmacist or a clinical pharmacist for 1 year following the creation of such data.
§ 81e
Consent management
(1) A physician, pharmacist and clinical pharmacist may refer to the data provided for in Section 81d (3) by means of the patient 's pharmaceutical record, unless the patient disagrees with the possibility of viewing the data provided for in Section 81d (3).
(2) The patient may at any time object to the possibility of viewing data displayed through his drug record. Such disagreement applies to all doctors, pharmacists and clinical pharmacists.
(3) In the event that the patient has expressed disagreement under paragraph 2, he may at any time withdraw his or her disagreement or consent to the consultation of data displayed through his or her drug record for a particular physician, pharmacist and clinical pharmacist, or withdraw that consent at any time.
(4) Consent management as part of the eRecept system ensures
(a) the registration of patients with expressed or withdrawn disagreements and the consent granted or withdrawn to allow access to the data referred to in Article 81d (3);
(b) the service of verifying the authorisation of access by a doctor, pharmacist and clinical pharmacist to the patient's medical records.
(5) Submission pursuant to paragraphs 2 and 3 shall be submitted by the patient to the Institute in electronic or paper form.
(6) The procedure for expressing or withdrawing the opposition and granting or withdrawing the consent of the patient to consult the data referred to in Section 81d (3) and the method of managing the records referred to in paragraph 4 (a) shall be laid down in implementing legislation.
§ 81f

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Regulation Information

CitationAct No. 262 / 2019 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Acts
Regulation Type-
Author-
CollectionCode of Laws
Date of Promulgation18.10.2019
Effective from01.12.2019
Effective until-
Status Valid
The regulation text is for informational purposes only.
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