Decree No. 537 / 2006 Coll.

Order on vaccination against infectious diseases

Valid Order Effective from 01.01.2007
537
DECLARATION
of 29 November 2006
on vaccination against infectious diseases
The Ministry of Health provides pursuant to § 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended by Act No. 392 / 2005 Coll. and Act No. 222 / 2006 Coll., ("the Act ') for the implementation of § 45 (2), § 46 (1), (2), (6) and § 47 (3) of the Act:
§ 1
Subject matter
This decree regulates
(a) the breakdown of the vaccination, the conditions for carrying out the vaccination and passive immunisation, the means of investigating immunity, the workplaces with a higher risk of infection and the conditions under which they may be assigned to such workplaces in connection with the specific vaccination of a natural person;
(b) cases where, prior to carrying out the regular and specific vaccination, a natural person is required to undergo an examination of the immunity status and is obliged to undergo a specific type of vaccination;
(c) the extent of the registration of the vaccination carried out in the vaccination certificate or in the child's and adolescent's health and medical documentation; and
(d) a model international certificate of vaccination against yellow fever in Czech and English.
§ 2
Breakdown of vaccination
(1) Vaccination against infectious diseases is divided into:
(a) regular vaccination against tuberculosis, diphtheria, tetanus, cough, Haemophilus influenzae b, communicable polio and viral hepatitis B, measles, rubella and mumps, pneumococcal diseases and viral hepatitis B;
(b) specific vaccination against viral hepatitis A and viral hepatitis B and rabies;
(c) emergency vaccination, which means vaccination of individuals to prevent infections in emergency situations;
(d) vaccination in accidents, injuries, non-healing wounds and before certain treatments against tetanus and rabies; and
(e) vaccination carried out at the request of a natural person wishing to be vaccinated against infections against which the vaccine is available.
(2) In the cases provided for in this Decree, periodic vaccination shall be carried out as:
(a) a primary vaccination involving one or more doses of vaccine needed to achieve specific resistance to the infection; and
(b) a re-vaccination where a single dose of vaccine is usually given to re-induce the required condition of resistance to the infection.
§ 3
Regular tuberculosis vaccination
(1) Vaccination shall be carried out for children with indications listed in Annex 2 to this Regulation. The vaccination indication referred to in Annex 2 to this Order shall be assessed by the doctor of the neonatal ward, in particular on the basis of the legal representative of the child completed by Part I of the questionnaire on the definition of tuberculosis risk, as set out in Annex 1 to this Order. The doctor of the neonatal ward shall complete part II of the questionnaire and complete the questionnaire, as part of the discharge report, to the registered physician for children and adolescents. If the child has an indication for vaccination in accordance with Annex 2 to this Order, he shall simultaneously inform the calmetisation centre. A registered practitioner for children and adolescents, usually within one month of taking custody, sends a child who meets the indication in Annex 2 to this Order and who has not yet been vaccinated against tuberculosis to a calmetisation site.
(2) For children who cannot be assessed as having fulfilled the indications set out in Annex 2 to this Ordinance by a doctor of the Neonatal Department, these indications are identified at first contact with the legal representative of the child by a general practitioner for children and adolescents. For the next procedure, the last sentence of paragraph 1 shall apply mutatis mutandis.
§ 4
Regular vaccination against diphtheria, tetanus, cough, Haemophilus influenzae b invasive disease, transmitted polio and viral hepatitis B
(1) The primary vaccination shall be carried out between the beginning of the ninth week following the birth of the child with two doses of hexavalent anti-diphtheria vaccine, tetanus, acellular component pertussis, invasive disease caused by Haemophilus influenzae b, viral hepatitis B and inactivated vaccine against transmissible polio ("hexavalent vaccine ') during the first year of life of the child, given at an interval of two months between doses, and the third dose given between the 11th and 13th month of the child's age. In children vaccinated against tuberculosis, the primary vaccination with hexavalent vaccine shall be performed from the beginning of the thirteenth week following the birth of the child, but always after healing the post-vaccination reaction after vaccination against tuberculosis. In premature children, vaccination shall be performed with three doses of vaccine administered at intervals of at least one month between the dose and the fourth dose administered at least six months after the third dose.
(2) Re-vaccination against diphtheria, tetanus and gavage should be carried out by vaccine against these infections with the acellular pertussis component from the time of completion of the fifth to the sixth year of age of the child.
(3) Re-vaccination against diphtheria, tetanus and acellular pertussis, together with the administration of the fourth dose of inactivated polio vaccine, shall be carried out from the tenth to the 11th year of age.
(4) For persons vaccinated pursuant to Article 4 (3), re-vaccination against tetanus shall take place from the age of 25 to the age of 25.
(5) Further re-vaccination against tetanus shall be carried out in natural persons who have been vaccinated in accordance with paragraphs 1 to 4 every 10 to 15 years.
(6) The primary vaccination against tetanus in adult individuals shall be performed with three doses given at the following intervals: the second dose 6 weeks after the first dose and the third dose 6 months after the second dose.
(7) The primary vaccination of the new-born HBsAg positive mothers shall be carried out with a single dose of hepatitis B viral vaccine no later than 24 hours after the birth of the child. The vaccination of these children shall continue from the sixth week following the birth of the child according to the Summary of Product Characteristics (1) of the hexavalent vaccine.
(8) In case of contraindication of administration of one of the components of the hexavalent vaccine, vaccination with an alternative vaccine shall be carried out.
§ 5
Regular vaccination against measles, rubella and mumps
(1) The primary vaccination shall be carried out with a live vaccine, not earlier than the first day of the thirteenth month following the birth of the child, but not later than the 18th month of the child's age.
(2) The administration of the second dose of measles, rubella and mumps vaccine should be from completion of the fifth year of age of the child until completion of the sixth year of age of the child.
§ 6
Regular vaccination against pneumococcal diseases
Vaccination against pneumococcal diseases shall be carried out in natural persons in long-term sick and elderly homes. In addition, vaccination against pneumococcal diseases shall be carried out in natural persons placed in homes for people with disabilities or in homes with a special regimen, where such individuals suffer from chronic non-specific respiratory disease, chronic heart, blood vessels or kidney disease or diabetes treated with insulin. Further vaccination against pneumococcal diseases should be carried out according to the Summary of Product Characteristics (1).
§ 7
Regular vaccination against viral hepatitis B
(1) Vaccination shall be carried out by administering three doses of vaccine to natural persons to be included in regular dialysis programmes.
(2) Vaccination as referred to in paragraph 1 shall not be carried out if a natural person has been vaccinated within the scope of § 4, 9 or 10 or if the level of antiHBs of antibodies is greater than 10 IU / litre after verification of the immunity status.
§ 9
Special vaccination against viral hepatitis B
(1) Vaccination should be performed 4), 5), 6) by the administration of three doses of vaccine to individuals who
(a) work at the places of work referred to in Article 16 (1) if they are active in the investigation and treatment of the natural persons to be cared for;
(b) are active in low-threshold programmes for drug users;
(c) are in close and regular contact with patients with viral hepatitis B or HBsAg;
(d) are not yet listed and newly admitted to homes for disabled persons or homes with a special regime;
(e) are exposed to risk exposure to biological material;
(f) study at a medical school or a medical school, and for students who are prepared at universities other than medical schools, for activities in medical institutions in the investigation and treatment of patients, for students in secondary and higher professional social schools in the field of activities in social services in the investigation and treatment of natural persons admitted to those institutions;
(g) provide off-road or outpatient social services;
h) are newly admitted as members of the Czech Prison Service;
(i) are included in retraining courses and provide for the care and care of persons in social services facilities and in health facilities; or
(j) handling hazardous waste in health and social services facilities.
(2) Vaccination as referred to in paragraph 1 shall not be carried out (4), (5) in a natural person with evidence of viral hepatitis B disease and in a natural person with an antibody titre against HBsAg exceeding 10 IU / litre and in natural persons who have been shown to have been vaccinated against viral hepatitis B.
§ 10
Special vaccination against viral hepatitis A and viral hepatitis B
Vaccination shall be carried out (5) for staff and members of the essential components of the integrated rescue system established by the Integrated Rescue System Act (2) newly admitted to work or service.
§ 11
Special vaccination against rabies
Vaccination shall be performed 5), 6) for natural persons working at the workplaces referred to in Section 16 (2).
§ 11a
Specific measles vaccination
(1) Vaccination shall be carried out by applying a single dose of vaccine to natural persons who are newly admitted to work or to service at an infectious or dermatoenerological workplace.
(2) The vaccination referred to in paragraph 1 shall not be carried out in a natural person with evidence of measles disease and in a natural person with positive IgG antibodies against measles virus.
§ 11b
Perform regular vaccination at a later age of the child
If, due to the health of the child, it is not possible to carry out periodic vaccination in accordance with § 3 to 5, such vaccination shall be carried out at a later age of the child, in accordance with the summary of data for each vaccine. Similarly, children of foreigners living in the Czech Republic or children whose vaccination has been started abroad will be treated.
§ 13
Vaccination against rabies or tetanus in accidents, injuries, non-healing wounds and before certain medical procedures
(1) Tetanus vaccination shall be carried out on injuries, injuries or non-healing wounds which are at risk of tetanus disease, and, where indicated, pre-operative, especially prior to rectal or colon surgery. Vaccination shall be carried out with an active immunisation vaccine according to the Summary of Product Characteristics (1) of that vaccine.
(2) Vaccination against rabies shall be carried out in the event of bite or injury by an animal suspected of being infected with rabies.
§ 13a
International yellow fever vaccination certificate
The model of the international certificate of vaccination against yellow fever in the Czech and English languages is set out in Annex 3 to this decree.
§ 14
Execution of vaccination
(1) Parenteral administration of the vaccine is carried out on each individual under aseptic conditions, with a separate sterile syringe and a separate sterile injection needle, or a separate pre-filled sterile syringe with a sterile injection needle.
(2) At the same time, live and inanimate vaccines can be vaccinated at different sites of the body. If different vaccines are not administered simultaneously, a 14-day interval shall be observed after the live vaccines are administered and 14 days after the non-live vaccines are administered; after vaccination against tuberculosis can be vaccinated not earlier than 2 months, but always after healing the initial reaction. In exceptional cases, where the medical condition of a natural person or the need to induce the required state of resistance so requires, those intervals may be shortened.
§ 15
Conditions for passive immunisation
(1) In the case of persons vaccinated in accordance with Article 13 (1), where a summary of the data on the tetanus vaccine is recommended, a hyperimmune antitetanic globulin is also administered.
(2) In the case of natural persons vaccinated pursuant to Article 13 (2), where a summary of the data on the preparation (1) for the rabies vaccine is recommended, a hyperimmune antirabic globulin is also administered.
(3) In newborn mothers of HBsAg positive vaccinated in accordance with § 4 (7), hyperimunic globulin against viral hepatitis B is also administered.
§ 16
Work places with higher risk of infectious diseases
(1) Pravivišt4), 5) with a higher risk of developing viral hepatitis B are surgical centres, the hemodialysis and infectious ward, the internal ward including long-term treatment of patients and the internal workplace performing invasive procedures, the anesthesiologic-resuscitation, intensive care units, laboratories working with human biological material, transfusions facilities, dental, pathological-anatomical, judicial, psychiatric and medical emergency services, and homes for elderly people, homes with disabilities, homes with special regime and asylum homes.
(2) Workplaces (4), (5) with a higher risk of rabies are laboratories where virulent strains of rabies are used.
§ 17
Conditions under which natural persons may be assigned to a higher risk of infectious disease
At the workplace referred to in § 16 (1) and (2), natural persons may be reclassified at the earliest after the second dose of the vaccine, provided that further vaccination is completed within the prescribed period.
§ 18
Scope of registration of vaccination carried out
The following information shall be entered in the vaccination certificate or in the child's and minor's health and vaccination licence: the disease or diseases against which it is vaccinated and the name of the vaccine, the date of its submission, the batch number, the signature and the stamp of the vaccinating physician. The scope of the entry into the vaccination medical file is regulated by a specific legislation3).
Transitional provisions
§ 19
(1) The primary vaccination provided for in Article 4 (1) shall begin in children born after 31 December 2006 with a hexavalent vaccine.
(2) Children who have started vaccination with hexavalent vaccine in accordance with the procedure laid down in Article 47 (1) (b) of the Act shall receive the fourth dose of this vaccine in 2007 in accordance with the last sentence of Article 4 (1), not later than 18 months of age.
(3) Basic vaccination against diphtheria, tetanus, cough, Haemophilic influenzae b and viral hepatitis B in infants born before 1 January 2007 shall be carried out and completed in accordance with the existing legislation.
(4) Regular vaccination against viral hepatitis B in children born before 1 January 2007 who have not been vaccinated against that disease under the current rules shall be carried out by administering the first dose to children in the first months after the birth of the child, the third dose being given no later than the third year of age of the child.
§ 20
(1) Re-vaccination against transmissible polio shall be carried out in 2007 in children born in 2005 with two doses of live vaccine administered separately in two stages in March and May in accordance with the existing legislation.
(2) The primary vaccination against transmissible polio shall be carried out in children born in 2006 by two doses of live vaccine administered separately in two stages in March and May according to existing legislation in 2007.
(3) Re-vaccination against portable polio shall be carried out in 2008 in children born in 2006 by two doses of live vaccine administered separately in two stages in March and May.
§ 21
(1) In 2007, children born from 1 May 1993 to 30 April 1994 shall receive a fifth dose of a booster vaccine against a child transmissible polio inactivated vaccine against that disease.
(2) In 2008, children born from 1 May 1994 to 30 April 1995 shall receive a fifth dose of a booster vaccine against a child transmissible polio inactivated vaccine against the disease.
(3) In 2009, children born from 1 May 1995 to 30 April 1996 shall receive a fifth dose of a booster vaccine against a child transmissible polio inactivated vaccine against that disease.
§ 22
Primary vaccination against viral hepatitis B started with natural persons who have been vaccinated under existing legislation shall also be completed under existing legislation.
§ 23
Specific vaccination against viral hepatitis B and rabies initiated in individuals who have been vaccinated under the existing legislation shall be completed in accordance with the existing legislation.
§ 24
Repeal
The following shall be deleted:
1. Decree No. 439 / 2000 Coll., on vaccination against infectious diseases.
2. Decree No. 478 / 2002 Coll., amending Decree No. 439 / 2000 Coll., on vaccination against infectious diseases.
3. Decree No. 30 / 2004 Coll., amending Decree No. 439 / 2000 Coll., on vaccination against infectious diseases, as amended by Decree No. 478 / 2002 Coll.
§ 25
Efficacy
This Decree shall take effect on 1 January 2007.
Minister:
Dr. Julinek v. r.

Příloha č. 1

Annex No 1 to Decree No 537 / 2006 Coll.
Questionnaire on the definition of tuberculosis risk

Příloha č. 2

Annex No 2 to Decree No 537 / 2006 Coll.
Indications for tuberculosis vaccination
1. One or both of the parents of the child or the sibling of the child or a member of the household in which the child lives had active tuberculosis.
2. The child, one or both of the parents of the child or of the sibling of the child, or a member of the household in which the child lives, was born or continuously resided for more than 3 months in a state with a higher incidence of tuberculosis than 40 cases per 100 000 inhabitants. The Ministry of Health shall publish annually a list of States with a higher incidence of tuberculosis within 30 days of the update by the World Health Organisation.
3. The child was in contact with a patient with tuberculosis.
4. The indication for vaccination is based on anamnestic data provided by the doctor of the neonatal ward or by a registered practitioner for children and young by legal representatives of the child.

Příloha č. 3

Annex No 3 to Decree No 537 / 2006 Coll.
MODEL INTERNATIONAL VACCINATION CERTIFICATE AGAINST RURAL IMMISSION

MODEL INTERNATIONAL CERTIFICATE OF VACCINATION AGAINST YELLOW FEVER

1) Paragraph 3 (1) of Act No. 378 / 2007 Coll., on Medicines and on the amendment of certain related laws (Law on Medicines).
2) Paragraph 4 (1) of Act No. 239 / 2000 Coll., on the Integrated Rescue System and on the amendment of certain laws, as amended by Act No. 320 / 2002 Coll.
3) Decree No. 385 / 2006 Coll., on Health Documentation, as amended by Decree No. 479 / 2006 Coll.
(4) Paragraph 3 (6) of the Annex to Council Directive 2010 / 32 / EU of 10 May 2010 implementing the Framework Agreement on the prevention of sharp injuries in hospitals and other health establishments concluded between HOSPEEM and EPSO.
5) Clause 6 (4) of the Annex to Council Directive 2010 / 32 / EU.
6) Point 3 of the Annex to Council Directive 2010 / 32 / EU. Article 14 (3), second subparagraph and the third sentence of point 10 of Annex III to Directive 2000 / 54 / EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from the risks associated with exposure to biological agents at work (seventh individual Directive within the meaning of Article 16 (1) of Directive 89 / 391 / EEC).

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Regulation Information

CitationDecree No. 537 / 2006 Coll., on vaccination against infectious diseases
Regulation TypeOrder
Author-
CollectionCode of Laws
Date of Promulgation08.12.2006
Effective from01.01.2007
Effective until-
Status Valid
Legal Areas: Administrative law Health
The regulation text is for informational purposes only.
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