Name of law Law amending and supplementing the law on health Named Bill a bill amending and supplementing the law on health date adopted 19/12/2013 number/year Official Gazette 1/2014 Decree No 270

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on health, adopted by the HLÌI National Assembly on 19 December 2013.

Issued in Sofia on 27 December 2013.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice: Zinaida Zlatanova

LAW

amending the Health Act (promulgated, SG. 70 by 2004; amend., SG. 46, 76, 85, 88, 94 and 103 by 2005, issue 18, 30, 34, 59, 71, 75, 81, 95 and 102 in 2006, issue 31, 41, 46, 53, 59, 82 and 95 (2007), no. 13, 102 and 110 since 2008. , PC. 36, 41, 74, 82, 93, 99 and 101 of 2009, PCs. 41, 42, 50, 59, 62, 98 and 100 by 2010, PC. 8, 9, 45 and 60 by 2011, issue. 38, 40, 54, 60, 82, 101, and 102 from 2012 and St. 15, 30, 66, 68, 99, 104 and 106 by 2013)

§ 1. In art. 37 following amendments and supplements shall be made:

1. Create a new para. 2-4:

"(2) for the issue of a health certificate for the export of products and goods with importance to human health, the person concerned shall submit an application to the Chief State health inspector, specifying:

1. name, registered office and Head Office of the person concerned;

2. the name of the State for which the product is exported or goods;

3. justification of the need for the issue of a health certificate;

4. for cosmetic products – data for the reference number under which the product has been notified in Notification gateway for cosmetic products by the European Commission under art. 13 of Council Regulation (EC) no 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342/59 of 22 December 2009), hereinafter referred to as "Commission Regulation (EC) no 1223/2009".

(3) an application under subsection. 2 shall apply:

1. data for single identification code of sole proprietors and legal persons from the commercial register, and for the companies registered in a Member State of the European Union or in a State party to the agreement on the European economic area – document for up-to-date registration under national law, issued by the competent authority of the country concerned;

2. the list of products and goods intended for export, the Bulgarian language, with the exact product name, brand, type of package and the name and address of the manufacturer, and for cosmetic products – and the category and type of cosmetic product;

3. evaluation of the safety of the cosmetic product, where the issue of the health certificate for the export of cosmetic products;

4. a document for paid fee.

(4) where the incomplete or irregularity of the documents referred to in para. 2 and 3, the applicant shall, within 7 working days shall be notified in writing and the time limits for the issue of a health certificate be suspended. "

2. Al are created. 5, 6 and 7:

"(5) the health certificate for the export of products and goods with importance to human health shall be issued within 15 working days from the filing of the application referred to in paragraph 1. 2, respectively, of the removal of the identified shortcomings or irregularities in the Al. 4.

(6) the request under paragraph 1. 2 may be filed by electronic means, under the conditions and pursuant to the law on electronic document and electronic signature law on e-governance.

(7) the refusal to issue a health certificate can be challenged under the administrative code.

3. the Previous para. 2, 3 and 4 shall become respectively al. 8, 9 and 10.

§ 2. Art is created. 37A:

"Art. 37. (1) at the Department of health shall establish and maintain a register of the issued health certificates for exports of products and goods with relevance to human health. The register is public and includes:

1. number and date of the export certificate;

2. name of the exporting firm;

3. name of the manufacturer;

4. the country to which the product will be exported;

5. a list of the products and goods referred to in the export certificate.

(2) the register referred to in para. 1 dedicating a separate section, the order in which shall be entered the persons applied for the issue of a health certificate to export, and describe the number and type of attached to the application documents. This section notes and file movement formed in the application.

(3) of the Ordinance under art. 37, para. 8 specify the conditions and the procedure for the keeping of the register under para. 1. "

§ 3. Article 49 shall be amended as follows:

"Art. 49. (1) Cosmetic products that are available in the market must be safe for human health, when used under normal or reasonably foreseeable conditions, taking into account their presentation, labelling, instructions for use and disposal after use, as well as all other instructions provided by the manufacturer, Distributor and importer.

(2) cosmetic products placed on the market are safe for human health, when:

1. good manufacturing practice is complied with in accordance with art. 8 of Regulation (EC) no 1223/2009;

2. the safety assessment has been carried out in accordance with art. 10 of Regulation (EC) no 1223/2009;

3. the requirements for the dossier with information on cosmetic product according to art. 11 of Council Regulation (EC) no 1223/2009; in cases where the file is stored on the territory of the Republic of Bulgaria, the principal provides easy access to him, to the competent authorities of the Bulgarian language; the file should be accessible to the public in electronic or other format to the address of the responsible person referred to on the label;


4. the provisions on sampling and analysis in accordance with art. 12 of Regulation (EC) no 1223/2009;

5. the notification requirements are met prior to release of the cosmetic product on the market pursuant to art. 13 and 16 of Regulation (EC) no 1223/2009;

6. compliance with the limits for substances in cosmetic products pursuant to art. 14, 15 and 17 of Council Regulation (EC) no 1223/2009;

7. compliance with the requirements relating to animal testing according to art. 18 of Regulation (EC) no 1223/2009;

8. labelling requirements are met in accordance with art. 19, paragraphs 1, 2, 5 and 6 of Regulation (EC) no 1223/2009; the information referred to in art. 19, paragraph 1, letter "b", "c", "d" and "e", and paragraphs 2, 3 and 4, must be written and the Bulgarian language;

9. compliance with the requirements concerning claims of products according to art. 20 of Regulation (EC) no 1223/2009;

10. requirements for access to public information in accordance with art. 21 of Regulation (EC) no 1223/2009;

11. requirements are met for the notification of serious adverse effects in accordance with art. 23 of Council Regulation (EC) no 1223/2009;

12. compliance with the requirements in relation to information on substances contained in cosmetic products, according to art. 24 of Regulation (EC) no 1223/2009. "

§ 4. Article 50 is amended as follows:

"Art. 50. (1) the Minister of health and the State bodies are competent health control authorities within the meaning of art. 34 (1) of Regulation (EC) no 1223/2009.

(2) in toxicology Clinic of the University Hospital for active treatment and emergency medical assistance "n.i. Pirogov" –, is a toxicological Center within the meaning of art. 13 (6) of Regulation (EC) no 1223/2009.

(3) information provided by the European Commission under art. 13 (1), (2) and (3) of Regulation (EC) no 1223/2009 is used by the authority under para. 2 only for the purposes of the implementation of the healing activity.

(4) the authority under para. 2 protects the confidentiality of the information received under paragraph 1. 2. "

§ 5. Article 51 shall be replaced by the following:

"Art. 51. (1) the Minister of health shall periodically review and assess the performance of the activity of the organs of public health controls in respect of the control of cosmetic products.

(2) the review and evaluation referred to in paragraph 1. 1 shall be carried out at least once every 4 years and the results thereof shall be communicated to the other Member States of the European Union, and the European Commission, and shall be made public by electronic means and, where appropriate, by other means in accordance with the provisions of art. 22 of Regulation (EC) no 1223/2009. "

§ 6. Article 52 shall be amended as follows:

"Art. 52. the Minister of health shall determine by Decree: 1. detailed rules for the submission of information under art. 19 (1) of Regulation (EC) no 1223/2009 on cosmetic products which are not pre-packaged or are packaged at the time of sale at the request of the user, or are pre-packaged for immediate sale;

2. the requirements for the efficacy of the products intended for protection from solar radiation, and predâvâvanite claims in respect of them;

3. chemical methods for checking the composition of cosmetic products. '

§ 7. In chapter three, section I, article is created. 83 (a):

"Art. 83. (1) in respect of nationals of another Member State of the European Union, which provides healthcare in Bulgaria in accordance with chapter two, section XII of the law on health insurance, apply recognized by medical science and practice methods and technologies, as well as medical standards, approved by the order of art. 6, al. 1 of the law on medical institutions, and the rules of good medical practice, adopted and approved by the order of art. 5, paragraph 4, of the Act on professional organizations of physicians and dental practitioners who apply for Bulgarian citizens.

(2) the persons referred to in para. 1 pay the cost of the health service, for which the hospital issued a detailed finansovootčeten document for the financial resources spent.

(3) medical institutions that provide healthcare services to nationals of other Member States of the European Union, cannot determine the prices of health services other than those for Bulgarian citizens. "

§ 8. In chapter four, section IV creates art. 144:

"Art. 144. (1) to establish the type and frequency of rare diseases, and for the purposes of planning and the provision of preventive, diagnostic and treatment activities on rare diseases, a national registry of patients with rare diseases.

(2) the conditions and procedure for registration of rare diseases are determined by Decree of the Minister of health.

(3) the Ordinance referred to in para. 2 define the conditions and criteria for medical institutions, who wish to participate in the European reference networks, and the order of the creation, designation and functioning of centres of expertise and reference networks for rare diseases. "

§ 9. Create art. 213 and 214 (b):

"Art. 213. (1) Who place on the market cosmetic products in breach of the requirements of art. 49, para. 2, item 2, 3, 5, 6, 8, 9, 11 and 12, shall be punished with fine 1500 BGN, and for repeated infringement – 3000 EUR

(2) when the offence under para. 1 was carried out by a sole trader, a penalty payment in the amount $ 3000 and under repeated violation – $ 6000.

(3) When the offence under para. 1 is committed by a legal person, the penalty payment in the amount EUR 6000, and repeated violation – 12 000.

Art. 213. (1) (b) That cosmetic products placed on the market in breach of the requirements of art. 49, para. 1, item 1, 4, 7 and 10 shall be fined 1000 BGN, and for repeated infringement – 2000 EUR


(2) when the offence under para. 1 was carried out by a sole trader, a penalty payment in the amount 2000 BGN, and for repeated infringement – 4000 EUR

(3) When the offence under para. 1 is committed by a legal person, the penalty payment in the amount EUR 4000, and at repeated infringement – $ 8000. "

§ 10. In § 1 of the additional provisions are made the following amendments and additions:

1. point 14 shall be replaced by the following:

"14." Kozmetičen product "means any substance or mixture intended to come into contact with any external part of the human body (epidermis, hair and hairy parts, nails, lips and external genital organs) or with the teeth and the mucous membranes (mukoznata membrane) of the oral cavity, either exclusively or primarily for the purpose of cleaning them, parfûmirane, a change in their appearance, their protection, maintaining them in good condition or correcting body odor."

2. a new item 38:

"38." producer of cosmetic products "is a natural or legal person who manufactures a product or have the design or manufacture of such a product and offer this cosmetic product on the market with their own name or trademark."

3. Create is that 39-42:

"39." distributor of cosmetic products "is a natural or legal person in the supply chain, other than the manufacturer or importer, which provides beauty product in the territory of the Member States of the European Union.

40. "importer of cosmetic products" is a natural or legal person established in the territory of the Member States of the European Union, which it places on the market a cosmetic product from a third country.

41. the "responsible person" is the manufacturer or his authorised representative established in the territory of a Member State of the European Union, or the importer or his authorised representative established in the territory of a Member State of the European Union, as well as the Distributor, when placed on the market with its product name or trademark or modifies a product that has already been placed on the market in a way that may affect compliance with the relevant requirements of Regulation (EC) no 1223/2009.

42. "rare disease" is a disease that is spread with no more than 5 per 10 000 persons of the population of the European Union. "

§ 11. In the additional provisions § 1 (b) shall be established: "§ 1 (b). This law provides the implementation of Council Regulation (EC) no 1223/2009 of the European Parliament and of the Council on cosmetic products.

§ 12. In the additional provisions § 1 is created in:

"§ 1 in. This law shall establish the requirements of Directive 2011/24/EC of the European Parliament and of the Council of 9 March 2011, on the application of patients ' rights in cross-border healthcare (OJ, L 88/45 of 4 April 2011). "

Transitional and final provisions

§ 13. Issued in the previous row until the entry into force of this law the health certificates for exports of products and goods with importance to human health, shall be valid until that time in them.

§ 14. Applications for issuing health certificates for the export of products and goods with importance to human health, submitted to the entry into force of this law shall be dealt with in the previous row, as applications for the issue of a health certificate for the export of cosmetic products and data are provided under art. 37, para. 2, item 4.

§ 15. In the law on health insurance (official SG. 70 of 1998; amend., SG. 93 and 153 of 1998, no. 62, 65, 67, 69, 110 and 113 in 1999, issue 1 and 64 in 2000, 41/2001, no. 1, 54, 74, 107, 112, 119 and 120 of 2002, no. 8, 50, 107 and 114 from 2003. , PC. 28, 38, 49, 70, 85 and 111 in 2004, PCs. 39, 45, 76, 99, 102, 103 and 105 of 2005, St. 17, 18, 30, 33, 34, 59, 80, 95 and 105, 2006, issue. 11 of 2007; Decision of the Constitutional Court No. 3 of 2007 – PCs. 26 of 2007; amend., SG. 31, 46, 53, 59, 97, 100 and 113 of 2007, PC. 37, 110 and 71 of 2008, PCs. 35, 41, 42, 93, 99 and 101 of 2009, PCs. 19, 26, 43, 49, 58, 59, 62, 96, 97, 98 and 100 by 2010, PC. 9, 60, 99 and 100 by 2011, issue. 38, 60, 94, 101 and 102 of 2012 and St. 4, 15, 20, 23 and 106 by 2013) make the following amendments and supplements: 1. In art. 35 item 8 is created:

"8. the cross-border healthcare in accordance with chapter two, section XII."

2. Article 36 shall be deleted.

3. In art. 78 Item 3 shall be repealed.

4. In chapter II creates section XII "cross-border healthcare" with art. 80 (e) – art. 80 h:

Section XII

Cross-border healthcare

Art. 80 (1) Zdravnoosigurenite persons have access to safe and high-quality cross-border healthcare regardless of the manner of its organisation, provision and financing.

(2) cross-border healthcare is a healthcare provided or prescribed in a Member State of the European Union, other than the Member State of affiliation.

(3) the persons referred to in para. 1 can exercise their rights of cross-border health care, when health care is included in the package of health actions financed from the budget of the NATIONAL HEALTH INSURANCE FUND or to the budget of the Ministry of health.

(4) the right to cross-border healthcare does not include:

1. the provision of organs for the purpose of transplantation, and access to such bodies;

2. long-term care to patients with chronic physical or mental disabilities that include services whose objective is the support and assistance in carrying out routine, everyday tasks for an extended period of time;

3. activities at the national and local immunization programs;

4. where, in applying the mechanisms for the coordination of social security systems or existing bilateral agreements with other Member States, including within its scope health insurance.


Art. 80. (1) in exercising their right to cross-border healthcare must be paid to the persons zdravnoosigurenite the medical establishment in the Member State of treatment cost of the health service.

(2) the persons referred to in para. 1 are entitled to be reimbursed the cost of the healthcare in the Member State of treatment up to the level of costs that the NATIONAL HEALTH INSURANCE FUND or the Department of health paid for the healthcare in the Republic of Bulgaria, but not in excess of the costs actually incurred.

(3) the right to reimbursement of the costs referred to in paragraph 1. 2 does not apply to healthcare provided the obligatory aggravated in the Republic of Bulgaria of hospitals established in its territory who do not have concluded contracts for the rendering of medical assistance with HEALTH INSURANCE and not funded or subsidised with funds from the budget of the Ministry of health.

(4) the conditions and procedures for exercising the right to cross-border healthcare shall be determined by an Ordinance of the Minister of health.

Art. 80. (1) by the Ordinance under art. 80, al. 4, at the suggestion of the Manager of the NATIONAL HEALTH INSURANCE FUND, define health services, medicinal products and medical devices for which a reimbursement of costs of cross-border healthcare requires prior authorization, as well as the conditions and procedures for the grant of prior authorisation.

(2) health care services, medicinal products and medical devices under para. 1 and the procedure for granting a prior authorization shall be notified and on the website of the national point of contact under art. 80 h, para. 1.

(3) prior authorisation under paragraph 1. 1 may be required in respect of the health services that:

1. is dependent on planning requirements associated with the need to ensure sufficient and permanent access to a high-quality treatment in the Republic of Bulgaria or in order to control costs and avoid waste of financial, technical and human resources, and includes accommodation of the patient in the hospital at least for one night, or require the use of highly specialised and significant costs associated with the medical infrastructure or medical equipment;

2. includes treatment that exposes the patient or the population at risk;

3. is provided by the medical establishment, which in some cases causes a serious and specific concerns about the quality or safety of the service, with the exception of health care, which are governed by the laws of the European Union, guaranteeing a minimum level of safety and quality.

(4) on request for prior approval HEALTH INSURANCE or the Ministry of health shall verify that the conditions laid down in Regulation (EC) No 883/2004 are met in respect of the person's demands for prior authorisation for receiving cross-border healthcare. When these conditions are met, prior authorization is given under that regulation, unless the patient requests otherwise.

(5) the national health insurance fund or the Department of health refused to give prior authorisation where:

1. in accordance with the opinion of a medical professional the patient will be exposed to a risk to his safety, which cannot be regarded as justified considering possible medical benefit to the patient from the area in cross-border healthcare;

2. it can be assumed with relative certainty that the population would be exposed to a significant risk to his safety as a result of cross-border healthcare;

3. If the healthcare is provided by the medical establishment, which causes a serious and specific concerns regarding compliance with the standards and guidelines for quality of service and patient safety, including provisions on supervision, whether these standards and guidelines are provided for in laws or regulations, or by accreditation systems established in the Member State of treatment;

4. health services may be provided on the territory of the Republic of Bulgaria within the time limit which is medically justifiable, taking into account the current state of health and the probable development of the condition of the patient.

(6) the national health insurance fund or the Department of health may refuse to give permission in advance, when healthcare was among the health activities, guaranteed by the budget of the NATIONAL HEALTH INSURANCE FUND or the Department of health, and when health services cannot be delivered on the territory of the Republic of Bulgaria in justified from a medical point of view term, on the basis of an objective medical assessment of the health condition , the history and the probable development of the patient's illness, the degree of pain for the patient and/or the nature of the damage to the patient at the time of the request for permission.

(7) the refusal under para. 6 subject to appeal pursuant to the administrative code.

Art. 80. (1) the national health insurance fund is a national point of contact in matters of cross-border healthcare.

(2) the national contact point shall provide patients information related to cross-border healthcare, and liases with other national contact points and the European Commission.


(3) the Ministry of health, regional health inspections, the Agency for persons with disabilities, medical institutions and professional organisations provide HEALTH INSURANCE upon request the information necessary for the implementation of its functions as a national contact point.

(4) the Bulgarian medical association, the Bulgarian Dental Association, the Bulgarian Association of health care professionals and the Bulgarian pharmaceutical Union provided upon request of the national contact point for the necessary information on the right to practice the medical profession listed in their records, including information on specific rights to provide services, or for any restrictions on their activities.

(5) institutions under para. 3 and 4 provide the NHF requested information within two days of receipt of the request.

(6) the information referred to in para. 3 and 4 and the terms and conditions of its submission shall be determined by the Ordinance under art. 80, al. 4. "

5. In the additional provisions § 1 (b) shall be established:

"§ 1 (b). Within the meaning of chapter two, section XII:

1. "health care" means health services provided by health professionals to patients in order to assess, maintain or restore their State of health, including the Administration, the implementation of medical regulations and the provision of medicinal products and medical devices.

2. the "aggravated" are:

a) persons, including members of their families and their survivors, which fall within the scope of article 2 of Regulation (EC) No 883/2004 and which are insured persons within the meaning of article 1 (c) of the said regulation, and (b)) the third-country nationals who fall within the scope of Regulation (EC) No 859/2003 of 14 May 2003 extending the provisions of Regulation (EEC) No 1408/71 and Regulation (EEC) No 574/72 to nationals of third countries who are not already covered by these provisions solely on the ground of their nationality or Regulation (EC) no 1231/2010 of the European Parliament and of the Council of 24 November 2010 to extend the scope of Regulation (EC) No 883/2004 and Regulation (EC) no 987/2009 to nationals of third countries which are not yet covered by these regulations solely on the ground of their nationality (OJ L 344/1 dated 29 December 2010) or which fulfil the conditions for entitlement to benefits under the legislation of the Member State of affiliation.

3. "Member State of affiliation" means:

a) to persons referred to in paragraph 2 (a) – the Member State which is competent to give the insured person prior authorisation to receive appropriate treatment outside the Member State of residence in accordance with Regulation (EC) No 883/2004 and Regulation (EC) no 987/2009;

(b)) to persons referred to in paragraph 2 (b) – the Member State which is competent to give the insured person prior authorisation to receive appropriate treatment in another Member State in accordance with Regulation (EC) No 859/2003 or regulation (EC) no 1231/2010; If no Member State responsible in accordance with these regulations, the Member State of affiliation is the Member State in which the person is insured or is entitled to benefits under the sickness under the legislation of that Member State.

4. "Member State of treatment" means the Member State in whose territory they actually provide health care to the patient. When telemedicine services assumes that health care is provided in the Member State in which the supplier is established on healthcare.

5. "health care professionals" are persons exercising the medical profession under art. 183, para. 1 of the Health Act.

6. the "patient" is a natural person who seeks to obtain or receive healthcare in a Member State.

7. "medicinal product" means a medicinal product within the meaning of the law on medicinal products for human use.

8. "medical device" is a medical device within the meaning of the law on medical devices.

9. "medical prescription" is a medical prescription for the purposes of the law on medicinal products for human use. "

§ 16. In the law on medicinal products for human use (official SG. 31 of 2007; amend., SG. 19 of 2008; Decision of the Constitutional Court No. 5 of 2008 – No. 65 of 2009; amend., no. 71 of 2008, no. 10, 23, 41, 88 and 102 of 2009, 59/98, and by 2010, issue 9, 12 , 60 and 61 by 2011, issue. 38, 60 and 102 from 2012 and St. 15 of 2013) make the following additions:

1. In art. 221 create al. 4 and 5:

"(4) the requirements for medical prescriptions, which are issued at the request of a patient, who intends to use them in another Member State, as well as the recognition and enforcement of such, issued in another Member State, shall be carried out under conditions and by an order determined by the Ordinance under para. 1.

(5) the reimbursement of medicinal products on medical prescription, executed in another Member State, shall take place under conditions and by an order determined by the Ordinance under art. 80, al. 4 of the law on health insurance. "

2. § 1 of the additional provisions establishes that 35A:

"35A." medical prescription "is a prescription of a medicinal product or a medical device, issued by a person who exercises a regulated medical profession, within the meaning of § 1, item 1 of the additional provisions of the law for the recognition of professional qualifications and who has the legal right to do so in the Member State in which he or she is issued a medical prescription."

§ 17. Within one month from the entry into force of this Act, the Minister of Health issued regulations on:

1. Article 37, para. 8, art. 52 and art. 114 a, para. (2);

2. Article 80, al. 4 of the law on health insurance.


§ 18. Within one month from the entry into force of this Act, the Minister of health to him the Ordinance under art. 221, para. 1 of the law on medicinal products for human use.

§ 19. The law shall enter into force on the day of its publication in the Official Gazette.

The law was adopted by the 42nd National Assembly on 19 December 2013 and is stamped with the official seal of the National Assembly.

President of the National Assembly: Mihail Mikov

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