S.L. 483.2 Art. 10Good Practice Guidelines.

(1) A quality system for blood establishments laid down in the Annexes to Directive 2005/62/EC implementing Directive

2002/98/EC of the European Parliament and the Council as regards

Community Standards and specifications relating to a quality system for Blood Establishments shall be established and maintained, taking into account, where relevant for blood establishments, the detailed principles and guidelines of good manufacturing practice, as referred to in the first sub-paragraph of Article 47 of Directive 2001/83/EC, and the Good Practice Guidelines in the Guide to the preparation, use and quality assurance of blood components, Appendix to Recommendation No. R (95)15 of the Committee of Minsters on the preparation, use and quality assurance of blood components adopted on 12 October 1995 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.

(2) Any blood or labile blood products imported from third countries and intended for the use or distribution in the Community must also adhere to the Quality system as specified in Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments, even in the stages prior to importation. SCHEDULE I

INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING (Regulation 3) Part A Information: Identification of the blood establishment; qualification and contact details of responsible persons; of hospital blood banks which it supplies. Part B description of the quality system, to include: Documentation, such as an organisation chart, including responsibilities responsible persons and reporting relationships; Documentation such as site master file or quality manual describing the quality system in accordance with Schedule IX; Number and qualification of personnel; Hygiene provisions; Premises and equipment; List of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing, distribution and recall blood components and for the reporting and recording of serious adverse reactions and events.

SCHEDULE II

REPORT OF THE BLOOD ESTABLISHMENT’S PRECEDING YEAR’S ACTIVITY report will include: Total number of donors who give blood and blood components; Total number of donations; An updated list of the hospital blood banks which it supplies; Total number of whole donations not used; Number of each component produced and distributed; Incidence and prevalence of transfusion transmissible infectious markers in donors of blood and blood components; Number of product recalls; Number of serious adverse events and reactions reported. SCHEDULE III

LABELLING REQUIREMENTS

The label on the component must contain the following information: - The official name of the component; - The volume or weight or number of cells in the appropriate); - The unique numeric or alphanumeric donation identification; - The name of producing blood establishment; - The ABO Group (not required of plasma intended fractionation); - The Rh D Group, either Rh D positive or Rh D negative for plasma intended only for fractionation); - The date or time of expiry (as appropriate); - The temperature of storage; - The name, composition and volume of anticoagulant and/or solution (if any).

SCHEDULE IV

BASIC TESTING REQUIREMENTS OR WHOLE BLOOD AND PLASMA DONATIONS

The following tests must be performed for whole blood and apheresis including autologous predeposit donations: - ABO Group (not required for plasma intended only for fractionation); - Rh D Group (not required for plasma intended only for fractionation);

Testing for the following infections in the donors: - Hepatitis B (HBs-Ag) - Hepatitis C (Anti-HCV) - HIV 1 and 2 (Anti-HIV 1 and 2) Additional tests may be required for specific components epidemiological situations. SCHEDULE V

INFORMATION REQUIREMENTS

(Regulation 5) Part A

to be provided to prospective donors of blood and blood components Accurate educational materials, which are understandable for members of general public, about the essential nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations, and the important benefits to patients. both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history, and the testing of donations and the significance of ‘informed consent’. For allogeneic donations, self-deferral, temporary and permanent deferral, and the reasons why individuals are donate blood or blood components if there could be a risk for the recipient. For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take place in the presence of health risk to the individual whether as donor or recipient of the autologous blood or blood components. Information on the protection of personal data: no unauthorised disclosure identity of the donor, of information concerning the donor's health, the results of the tests performed.

reasons why individuals are not to make donations which may be detrimental to their health.

Specific information on the nature of the procedures involved either in the allogeneic or autologous donation process and their respective associated For autologous donations, the possibility that the autologous blood blood components may not suffice for the intended transfusion requirements.

Information on the option for donors to change their mind about donating to proceeding further, or the possibility of withdrawing or self-deferring at any time during the donation process, without any undue embarrassment or discomfort. reasons why it is important that donors inform the blood establishment subsequent event that may render any prior donation unsuitable for transfusion.

Information on the responsibility of the blood establishment to inform the r, through an appropriate mechanism, if test results show any abnormality of significance to the donor's health. Information why unused autologous blood and blood components will be discarded and not transfused to other patients. Information that test results detecting markers for viruses, such as HIV, HCV or other relevant blood transmissible microbiologic agents, will in donor deferral and destruction of the collected unit. Information on the opportunity for donors to ask questions at any time.