Authorised blood establishments
All blood establishments which are authorised for collection, processing, storage and distribution of human blood and blood components are inspected on regular basis according to requirements of Directive 2002/98/EC and relevant Commission Directives (EU).
The organisation of supply of blood components intended for transfusion and plasma derived medicinal products for health care facilities are governmental functions delegated by the Ministry of Health to the State Blood Donor centre, which also employs the largest blood establishment, provides donor testing nationwide and distributes fresh frozen plasma for fractionation.
The State Blood Donor centre’s blood establishment is authorised and inspected also on requirements of Good Practice Guidelines jointly developed by the Commission and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe and published by the Council of Europe (thereinafter- GPG). According to Recital (4) of Preamble of the Commission Directive (EU) 2016/1214 the GPG fully reflect the detailed principles and guidelines of good manufacturing practice established under Article 47 of Directive 2001/83/EC (4) which are relevant for blood establishments and their quality systems.
Actual status of the State Blood Donor centre’s authorisation as well as all other blood establishments is available on register of authorised blood establishments, these data must be updated within 3 working days. Register is available in Latvian only (please click on “Novērtētie asins kabineti, asins sagatavošanas nodaļas un Valsts asinsdonoru centrs” and then to “Asins sagatavošanas nodaļas un Valsts asinsdonoru centrs”).
On your disposal there is a translation of head row of table:
Please note that an authorisation status is stated in column “Status” and are as follows:
Derīgs - authorised, or Apturēts – suspended.
In case when authorisation is revoked or ceased the information regarding authorisation in question is being removed from the Register.
National legislation does not require neither to inspect blood establishments according to, nor issuing the certificate of compliance on requirements of Good manufacturing practices (GMP) as it is not a requirement of Directive 2002/98/EC. Moreover, according to Recital (4) of Preamble of the Commission Directive (EU) 2016/1214 the GPG fully reflect the detailed principles and guidelines of good manufacturing practice established under Article 47 of Directive 2001/83/EC (4) which are relevant for blood establishments and their quality systems.
As stated on GMP Annex 14 “Manufacture of Medicinal Products Derived from Human Blood or Plasma” paragraph 2.5. where specific processing steps in relation to plasma for fractionation take place in a blood establishment, the specific appointment of a Qualified Person may, however, not be proportionate given the presence and responsibility of a Responsible Person. To address this particular situation and to ensure the legal responsibilities of the Qualified Person are properly addressed, the fractionation plant/manufacturer should establish a contract in accordance with Chapter 7 of the GMP Guide with the blood establishment that defines respective responsibilities and the detailed requirements in order to ensure compliance. The Responsible Person of the blood establishment and the Qualified Person of the fractionation/manufacturing plant should be involved in drawing up this contract. The Qualified Person should ensure that audits are performed to confirm that the blood establishment complies with the contract.
Authorised tissue establishments
Register is available in Latvian only (please click on "Novērtētie audu centri"); data must be updated in 3 working days.
On your disposal there is a translation of head row of table:
| Name of Health care institution/ Name of Tissue establishment | Responsible person/ Contact information | Authorisation number | Date of issue | Status |
|---|
Please note that an authorisation status is marked with capital letters in brackets in column “Status” and are as follows:
(A) - authorised, (R) - revoked, (S) - suspended, (C) -ceased
For authorisations issued prior to 2014 validity period end date is stated in the same column.
Information regarding authorisation of tissue establishments you can also find in EU hosted Coding platform that allows public free of charge access to the EU Tissue Establishments Compendium. Data in Compendium must be updated in 10 working days.
Please note that health care institutions that only carry out donation, and/or testing, and/or procurement (i.e. procurement organisations) are not included in the Compendium, however according to Latvian legislation they must be authorised either as tissue establishments or they must be included in another tissue establishment authorisation under Annex II (2.pielikums).
Issued authorisations with Annexes in PDF format are available by opening the link of authorisation number in the column “Atļaujas/sertifikāta numurs”. Authorisations whose link is inactive are either revoked, suspended, ceased or with expired validity date.
Authorised human organ procurement organisations / transplantation centres
Register is available in Latvian only (please click on "Novērtētās cilvēka orgānu ieguves organizācijas, transplantācijas centri"); data must be updated in 3 working days.
On your disposal there is a translation of head row of table:
Name of Health care institution/ Contact information | Authorised activities | Authorisation number | Date of issue | Status |
|---|
Please note that authorisation status is marked with capital letters in brackets in column “Status” and are as follows:
(A) - authorised, (R) - revoked, (S) - suspended, (C) -ceased
