Decree of the Ministry of Health No. 439 / 2000 Coll.

Decree of the Ministry of Health on vaccination against infectious diseases

Valid Order Effective from 01.01.2001
439
DECLARATION
Ministry of Health
of 6 December 2000
on vaccination against infectious diseases
According to § 108 (1) for the implementation of § 45, § 46 (1), (2) and (6) and § 47 (2) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, hereinafter referred to as "the Act ':
§ 1
Scope
This Decree provides for the breakdown of the vaccination and the conditions for the carrying out of the vaccination, the means of investigating immunity, the workplaces with a higher risk of infection, as well as the conditions under which they may be assigned to such workplaces in connection with the specific vaccination of a natural person.
§ 2
Vaccination
(1) Vaccination against infectious diseases is carried out as:
(a) periodic vaccination which means vaccination of all natural persons of certain age groups or vaccination of groups of natural persons defined by a higher risk of infection for reasons other than occupational;
(b) specific vaccination, which means vaccination of natural persons working at workplaces with a higher risk of infection;
(c) emergency vaccination, which means vaccination of individuals to prevent infections in emergency situations;
(d) vaccination in accidents, injuries and non-healing wounds as well as before certain medical procedures, in particular operations on the rectum and colon, to prevent early infections;
(e) vaccination before travelling abroad, which means vaccination of individuals to prevent infections during their stay abroad, particularly in areas with a higher risk of infection;
(f) further vaccination at the request of natural persons not belonging to the group referred to in (a) to (e) who wish to be protected against infections against which the vaccine is available.
(2) Basic vaccination means the administration of one or more doses of vaccine needed to achieve specific resistance to the infection. The re-vaccination means the administration of a single dose of vaccine, which, after primary vaccination, reproduces the required resistance to the infection.
§ 3
Regular tuberculosis vaccination
(1) The primary vaccination shall be carried out no earlier than the fourth day and no later than the end of the sixth week following the birth of the child. Three to four months after vaccination, an examination of the injection site and regional nodes shall be carried out. If no local reaction is detected, re-vaccination shall normally be carried out after completion of the primary vaccination against other infectious diseases in the case of a negative tuberculin test.
(2) If the primary vaccination cannot be carried out within a given period, it shall be postponed only after all other primary vaccination carried out in the framework of the regular vaccination of children, except for infants belonging to the dispensary group of contacts with active tuberculosis, who are vaccinated preferably before the other vaccination. Only children with negative tuberculin tests are vaccinated.
(3) Re-vaccination shall be carried out from the 11th to the 12th year of age of the child after a previous tuberculin test has been carried out in tuberculosis negative children.
§ 4
Regular vaccination against diphtheria, tetanus, cough and Haemophilus influenzae b
(1) The primary vaccination shall be carried out from the beginning of the ninth week following birth, but always until the recovery of the post-vaccination reaction after vaccination against tuberculosis, by three doses given at intervals of 1 to 2 months, so that the third dose is administered until the end of the first year of life, and the fourth dose at the eighteenth to twentieth months of life.
(2) Re-vaccination shall be carried out with diphtheria, tetanus and cough from completion of the fifth to completion of the sixth year of age.
(3) Further re-vaccination against tetanus shall be carried out with the tetanus vaccine from the 14th to the 15th year of age of the child and then for persons who have been vaccinated under these and previous paragraphs every 10 to 15 years.
(4) The primary tetanus vaccination in the elderly is performed with three doses given at intervals of the second dose 6 weeks after the first dose and the third dose 6 months after the second dose.
§ 5
Regular vaccination against portable polio
(1) The primary vaccination shall be carried out with two doses of live vaccine given separately in two stages (March, May) in children born in the previous year.
(2) The re-vaccination shall be carried out in the calendar year following the year in which the primary vaccination was carried out, again in two stages in March and May, and in the case of children from the 13th to the 14th year of age in the second phase in May.
(3) The application of five doses of vaccine is considered to be a complete vaccination.
§ 6
Regular vaccination against measles, rubella and mumps
(1) The primary vaccination shall be carried out with a live vaccine at the earliest the first day of the 15th month of life.
(2) The re-vaccination shall be carried out 6 to 10 months after the primary vaccination has been carried out and, where appropriate, thereafter.
§ 7
Regular vaccination against viral hepatitis B
(1) The first dose of vaccine shall be given to children in the first months of life, depending on the type of vaccine, and the third dose of vaccine shall be given no later than the end of the three years of age of the child. If the newborn HBsAg is a positive mother, vaccination shall be carried out prior to the administration of the tuberculosis vaccine (§ 3 (1)) no later than 24 hours after birth.
(2) In the case of children who have not been vaccinated against hepatitis B virus as referred to in paragraph 1, vaccination shall be carried out from the twelfth to the thirteenth year of age of the child.
(3) Vaccination shall also be carried out for natural persons
(a) which are to be included in regular dialysis programmes;
(b) newly admitted to social welfare institutions, except pensioners' and pensioners' homes;
(c) in cases of sexual contact with natural persons with viral hepatitis B disease or HBsAg carrier,
(d) living in the same household with natural persons with viral hepatitis B disease or HBsAg carrier, where such vaccination is imposed by the public health authority.
§ 8
Regular vaccination against influenza and Streptococcal pneumoniae
(1) Influenza vaccination shall be carried out each year for natural persons in long-term care centres, pensioners' homes and pensioners' homes. Vaccination shall also be carried out in natural persons located in social care institutions if they suffer from chronic non-specific respiratory diseases, chronic heart, vascular and kidney disease or diabetes.
(2) For the natural persons referred to in paragraph 1, vaccination against diseases caused by Streptococcal pneumoniae shall be carried out only once and shall be continued according to the approved Summary of Product Characteristics (2).
§ 9
Regular vaccination against Viral Hepatitis A and Viral Hepatitis B with needle injury
Vaccination against viral hepatitis And 1 dose and viral hepatitis B 3 doses should be administered after needle injury after testing for immune status in those individuals who have not shown antibodies to viral hepatitis The antiHBs antibody level will be below 10 IU / litre. Vaccination against hepatitis B virus shall not be carried out if a person has been vaccinated within the scope of Sections 7, 11 and 11a.
§ 11
Special vaccination against viral hepatitis B
(1) Specific vaccination against hepatitis B virus shall be carried out for natural persons working at the workplaces referred to in Article 20 (2), if they are active in the investigation and treatment of those who are to be cared for, in the handling of medical waste and in those working in low-threshold programmes for drug users, before their activity in those workplaces begins. It shall also be carried out with the students of medical faculties and medical schools, and with students prepared at universities other than medical faculties, for activities in medical institutions in the investigation and treatment of patients and in the students in secondary and higher professional social schools prepared for activities in social care institutions in the investigation and treatment of individuals admitted to those institutions.
(2) Vaccination may not be submitted to persons referred to in paragraph 1 with evidence of hepatitis B disease and those with an antibody titre against HBsAg exceeding 10 IU / litre.
§ 11a
Special vaccination against viral hepatitis A and viral hepatitis B
Special vaccination against viral hepatitis A and Viral Hepatitis B shall be performed for employees of essential components of the integrated rescue system3) admitted to work or service as from the date of entry into force of this Decree.
§ 12
Special vaccination against rabies
Specific anti-rabies vaccination shall be carried out on natural persons for work at the workplaces referred to in Section 20 (3) before their work at those workplaces begins.
§ 13
Special vaccination against influenza and Streptococcal pneumoniae
Specific vaccination against influenza and diseases caused by Streptococcal pneumoniae shall be carried out for natural persons working at the workplaces referred to in Article 20 (3), in the case of influenza vaccination every year, in the case of Streptococcal pneumoniae, in the case of vaccination, in accordance with the approved Summary of Product Characteristics (2).
§ 14
Vaccination against rabies and against tetanus in accidents, injuries and non-healing wounds
(1) Tetanus vaccination shall be carried out in accidents, injuries and non-healing wounds at the risk of tetanus disease and, in indicated cases, pre-operative. The vaccination shall be carried out according to the scheme set out in the Annex.
(2) Vaccination against rabies shall be carried out when bitten or injured by an animal suspected of rabies infection.
§ 15
Execution of vaccination
(1) Parenteral administration of the vaccine is carried out with each individual under aseptic conditions, a separate sterile syringe and a separate 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 at the same time, follow the 1 month interval after administration of live vaccines and 14 days after administration of non-live vaccines, after vaccination against tuberculosis they may be vaccinated in at least two months, but always after healing the initial reaction. In exceptional cases, those intervals may be shortened.
§ 16
Contraindications
(1) The assessment of whether the vaccination is indicated or contraindicated in the vaccinated person is the responsibility of the vaccination physician, in the event of permanent contraindication to the competent expert. Evidence of permanent contraindication, which must be part of the medical file, shall be provided by a written statement by the medical practitioner or by a record by the vaccinating doctor of the opinion of the medical practitioner, stating his name, surname and date of communication of the opinion. An expert in neurology or in immunology, allergology, neonatology and infection shall be considered as a specialist.
(2) The contraindications to the use of the vaccine are provided in the approved product data and, where appropriate, in the package leaflet. 1)
(3) Persons with established permanent contraindications to vaccination against:
(a) the gum cough may be vaccinated with an acellular (non-cellular) vaccine,
(b) portable polio may be vaccinated with an inanimate vaccine.
(4) The contraindications to the administration of a cough vaccine are:
(a) severe allergic reactions and hyperreactions following previous administration of the vaccine,
(b) encephalopathy, epilepsy or epileptic seizure induced by previous administration of a cough vaccine;
(c) severe diseases of the central or peripheral nervous system with uncertain prognosis;
(d) progressive neurological disease.
§ 17
Procedure for the occurrence of an adverse reaction and a defect of the vaccine
The definition and reporting system of undesirable, serious adverse and unexpected adverse effects and defects in the quality of the vaccine are laid down in a separate regulatory act (1).
§ 18
Cases where an examination of the immunity and the means of its investigation is required
Prior to the re-vaccination of children against tuberculosis in accordance with § 3 (1) and (3), an immunity test for tuberculin shall be carried out and re-vaccination carried out only for tuberculin negative.
§ 19
Conditions for passive immunisation
(1) In the case of persons vaccinated under Paragraph 14 (1), passive immunisation shall be carried out by administering human hyperimmune antitetanic globulin in the cases listed in the Annex.
(2) For persons vaccinated under Paragraph 14 (2) where the manufacturer's approved package leaflet for the use of the rabies vaccine so recommends, a hyperimmune antirabic globulin shall also be administered.
(3) In newborns of HbsAg positive mothers vaccinated in accordance with § 7 (2), hyperimune globulin against viral hepatitis B is also administered.
§ 20
Work site with higher risk of infection
(1) Workplaces at a higher risk for viral hepatitis B are surgical centres, the isolation of haemodialysis and infectious, the internal separation including the treatment of long-term sick and internal workplaces performing invasive procedures, the anaesthesiologic-resuscitation, intensive care units, the laboratory of microbiological, hematologic, biochemical and immunological centres, the laboratory of transfusion stations, the dental, pathological-anatomical, medical, psychiatric and medical emergency services as well as the homes of pensioners, home-pensions for pensioners and social care institutions.
(2) Work sites with a higher risk of rabies are laboratories where virulent strains of rabies are used.
(3) Work places with a higher risk of influenza and diseases caused by Streptococcal pneumoniae are long-term hospitals, nursing homes, pensioners' homes, pensions for pensioners and social care institutions.
§ 21
Conditions under which natural persons may be assigned to a higher risk of infectious disease
In the workplace referred to in Article 20 (2), natural persons who have not yet been active on them may be included in the context of a specific vaccination not earlier than after the second dose of the vaccine, provided that further vaccination is completed within the prescribed period.
§ 22
Details of the vaccination record
The record shall indicate the type of vaccine, the date of submission, the batch number, the signature and the stamp of the vaccinating physician, and the details of the vaccination carried out, paid by the natural person who requested regular, special or exceptional vaccination with a vaccine other than that provided by the competent public health authority.
Transitional and final provisions
§ 23
Vaccination against invasive disease caused by Haemophilus influenzae b pursuant to § 4 and vaccination against viral hepatitis B pursuant to § 7 (2) and (3) shall commence six months after the entry into force of this Decree.
§ 24
They shall be deleted:
1. Decree No. 48 / 1991 Coll., on vaccination against communicable diseases,
2. Decree No. 527 / 1991 Coll., amending Decree of the Ministry of Health of the Czech Republic No. 48 / 1991 Coll., on vaccination against communicable diseases,
3rd Decree No. 19 / 1994 Coll., amending and supplementing the Decree of the Ministry of Health of the Czech Republic No. 48 / 1991 Coll., on vaccination against communicable diseases, as amended by Decree No. 527 / 1991 Coll.
§ 25
This decree shall take effect on 1 January 2001.
Minister:
Prof. MUDr. Fisher, CSc.

Annex to Decree No 439 / 2000 Coll.
Immunoprophylaxis of tetanus in injury
SkupinaAnatoxinHyperimunní lidský
antitetanický
imunoglobulin
Řádně očkovaní do 15 let věku - -
Řádně očkovaní nad 15 let věku
do 5 let po očkování
nad 5 let po očkování
-
0,5 ml
-
-
Neúplné očkování
- 1 dávkou v době 3 - 6 týdnů před poraněním
- 2 dávkami v době 3 týdnů - 10 měsíců před poraněním
0,5 ml


0,5 ml
-

-
Neočkovaní nebo neúplně očkovaní s intervaly jinými
než uvedenými výše
0,5 ml*dávka dle
příbal. informace
Osoby nad 60 let věku
s dokladem o očkování v posledních 10 letech
bez takového dokladu
0,5 ml

0,5 ml*
-
dávka dle
příbal. informace
* Note: The primary vaccination according to § 4 is continued.
1) Paragraph 52 (1) and (2) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws.
2) Paragraph 2 (20) of Act No. 79 / 1997 Coll., as amended by Act No. 149 / 2000 Coll. and Act No. 129 / 2003 Coll.
3) Article 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.

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Regulation Information

CitationDecree of the Ministry of Health No. 439 / 2000 Coll., on vaccination against infectious diseases
Regulation TypeOrder
Author-
CollectionCode of Laws
Date of Promulgation15.12.2000
Effective from01.01.2001
Effective until-
Status Valid
Legal Areas: Administrative law Health
The regulation text is for informational purposes only.
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