and Cells Regulations, 2016

L.N. 368 of 2016

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Equivalent Standards of Quality and Safety of Imported Tissues

and Cells Regulations, 2016

IN exercise of the powers conferred by article 16 of the Human

Blood and Transplants Act, the Minister for Health, after consultation

with the Licensing Authority, has made the following regulations:-

(1) The title of these regulations is the Equivalent

Standards of Quality and Safety of Imported Tissues and Cells

Regulations, 2016.

(2) The scope of these regulations is to transpose Commission

Directive 2015/566/EU of 8 April 2015 implementing Directive

2004/23/EC as regards the procedure for verifying the equivalent

standards of quality and safety of imported tissues and cells.

(3) These regulations apply to the importation of human

tissues and cells for human application and manufactured products

derived from human tissues and cells intended for human application

Provided that these regulations shall not apply to

(a)

the import of tissues and cells provided for under

regulation 16 of the Tissues and Cells (Quality and Safety)

Regulations;

(b) the import of tissues and cells which are directly

authorised in case of emergencies;

(c)

blood and blood components as defined under the

Blood (Quality and Safety) Regulations; and

(d) organs and parts of organs as defined under the

Tissues and Cells (Quality and Safety) Regulations.

Minimum requirements concerning the information and

documentation to be provided by importing tissue establishment

applicants when applying to be accredited, designated, authorised

or licensed for the purpose of import activities

When applying for an accreditation, designation, authorisation

or licence for the purpose of import activities, the importing tissue

establishment applicant shall, unless already provided as part of

previous applications for accreditation, designation, authorisation or

licensing as a tissue establishment or importing tissue establishment,

provide the most up-to-date information and, for Part F,

documentation on the following

A. General Information on the Importing Tissue Establishment (ITE)

1. Name of the ITE (Company name).

2. Visiting address of the ITE.

3. Postal address of the ITE (if different).

4. Status of the applicant ITE: It should be indicated if this is

the first application for accreditation, designation, authorisation or

licensing as an ITE or, where applicable, whether this is a renewal

application. Where the applicant is already accredited, designated,

authorised or licensed as a tissue establishment, the TE compendium

code should be provided.

5. Name of the applying unit (if different from the company

name).

6. Visiting address of the applying unit.

7. Postal address of the applying unit (if different).

8. Name of the site of reception of imports (if different from

the company name and applying unit).

9. Visiting address of the site of reception.

In these regulations unless the context otherwise requires

"the Authority" means the Licensing Authority;

"emergency" means any unforeseen situation in which there is

no practical alternative other than to urgently import tissues and cells

from a third country into Malta for immediate application to a known

recipient or known recipients whose health would be seriously

endangered without such an import;

"importing tissue establishment" means a tissue bank or a unit

of a hospital or another body established in Malta which is a party to a

contractual agreement with a third country supplier for the import

into Malta of tissues and cells coming from a third country intended

for human application;

"one-off import" means the import of any specific type of tissue

or cell which is for the personal use of an intended recipient or

recipients known to the importing tissue establishment and the third

country supplier before the importation occurs. Such an import of any

specific type of tissue or cell shall normally not occur more than once

for any given recipient. Imports from the same third country supplier

taking place on a regular or repeated basis shall not be considered to

be "one-off imports";

"third country supplier" means a tissue establishment or another

body, established in a third country, which is responsible for the

export to Malta of tissues and cells it supplies to an importing tissue

establishment. A third country supplier may also carry out one or

more of the activities, which take place outside of Malta, of donation,

procurement, testing, processing, preservation, storage or distribution

of tissue and cells imported into Malta.

Certificate of Accreditation, Designation, Authorisation or Licence

to be issued by the competent authority or authorities to importing

tissue establishments

(1) The Authority shall, without prejudice to the Accreditation,

provisions of article 1(3), ensure that all imports of tissues and cells designation

authorisation or

from third countries are undertaken by importing tissue licensing

Authority.

establishments accredited, designated, authorised or licensed by it for

the purposes of those activities.

(2) The Authority, after having obtained the information set

out in Schedule I and after having verified that the importing tissue

establishment complies with the relevant legislation, shall

(a)

accredit, designate, authorise or licence

the

importing tissue establishment to import tissues and cells;

(b) indicate any conditions which apply on the

importing tissue establishment such as restrictions on the types

of tissues and cells to be imported or the third country supplier

to be used; and

(c)

issue the importing tissue establishment with the

certificate set out in Schedule II.

Minimum requirements concerning the documentation to be made

available to the competent authority or authorities by tissue

establishments intending to import tissues and cells from third

countries

With the exception of one-off imports which have been

exempted from these documentation requirements, the applicant

importing tissue establishment shall make available and, unless

already provided as part of previous applications for accreditation,

designation, authorisation or licensing as an importing tissue

establishment or tissue establishment, shall provide when requested

by the competent authority or authorities the most up-to-date version

of the following documents regarding the applicant and its third

country supplier(s).

A. Documentation relating to the importing tissue establishment

1. A job description of the Responsible Person and details of

his/her relevant qualifications and training record as laid down in

Tissues and Cells (Quality and Safety) Regulations;

2. A copy of the primary label, repackage label, external

package and transport container;

3. A list of relevant and up-to-date versions of standard

operating procedures (SOPs) relating to the establishment's import

activities including SOPs on applying the Single European Code,

reception and storage of imported tissues and cells at the importing

tissue establishment, management of adverse events and reactions,

management of recalls and traceability from donor to recipient.

B. Documentation relating to the third country supplier or suppliers

1. A detailed description of the criteria used for donor

identification and evaluation, information provided to the donor or

donor family, how consent is obtained from the donor or donor family

and whether the donation was voluntary and unpaid or not;

2. Detailed information on the testing centre(s) used by third

country suppliers and the tests performed by such centres;

3. Detailed information on the methods used during the

processing of the tissues and cells including details of the validation

for the critical processing procedure;

4. A detailed description of the facilities, critical equipment

and materials and criteria used for quality control and control of the

environment for each activity carried out by the third country

supplier;

5. Detailed information on the conditions for release of

tissues and cells by the third country supplier or suppliers;

6. Details of any sub-contractors used by the third country

suppliers including the name, location and activity undertaken;

7. A summary of the most recent inspection of the third

country supplier by the third country competent authority or

authorities including the date of the inspection, type of inspection and

main conclusions;

8. A summary of the most recent audit of the third country

supplier carried out by, or on behalf of, the importing tissue

establishment.

9. Any relevant national or international accreditation.

(1) The Authority shall every two years organise

inspections and other control measures of importing tissue

establishments and, where appropriate, their third country suppliers

and ensure that the importing tissue establishment carries out

appropriate controls to ensure quality and safety standards of the

imported tissues and cells.

Furthermore, the Authority may suspend or revoke the

accreditation, designation, authorisation or licence, in whole or in

part, of an importing tissue establishment if the inspections or other

control measures demonstrate that such importing tissue

establishment no longer meets the requirements set out in these

regulations.

(2) All inspections and other control measures shall be carried

out by an official, duly authorised in writing, who shall have the

authority to

(a)

inspect the importing tissue establishment and,

where necessary, the activity of any third country supplier;

(b) evaluate and verify the procedure and activities

carried out by the importing tissue establishment and the

facilities of the third country supplier that are relevant to ensure

the quality and safety standards of the tissues and cells to be

imported; and

(c)

examine any documents or other records that are

relevant for the evaluation and verification.

(3) The Authority shall, upon a justified request from another

competent authority of another Member State, or from the

Commission, provide information on the results of inspection and

other control measures relating to importing tissue establishments and

third country suppliers. The appropriate measures to be taken shall be

decided by the Authority after consulting with the requesting

competent authority.

(4) Where an on-site inspection takes place following a

request, the Authority shall agree with the requesting competent

authority on whether and how such authority shall participate in the

inspection. The final decision shall be taken by the Authority upon a

reasoned explanation to the requesting competent authority.

Minimum requirements concerning the contents of written

agreements between importing tissue establishments

and their third country suppliers

With the exception of one-off imports which have been

exempted from these requirements, the written agreement between

the importing tissue establishment and the third country supplier shall

contain at least the following provisions.

1. Detailed information on the specifications of the importing

tissue establishment aimed at ensuring that the quality and safety

standards laid down in Tissues and Cells (Quality and Safety)

Regulations are met and the mutually agreed roles and

responsibilities of both parties in ensuring that imported tissues and

cells are of equivalent standards of quality and safety;

2. A clause ensuring that the third country supplier provides

the information set out in section B of Schedule III to the importing

tissue establishment;

3. A clause ensuring that the third country supplier informs

the importing tissue establishment of any suspected or actual serious

adverse events or reactions which may influence the quality and

safety of tissues and cells imported or to be imported by the importing

tissue establishment;

4. A clause ensuring that the third country supplier informs

the importing tissue establishment of any substantial changes to its

activities, including any revocation or suspension, in part or in full, of

its authorisation to export tissue and cells or other such decisions of

non-compliance by the third country competent authority or

authorities, which may influence the quality and safety of tissues and

cells imported or to be imported by the importing tissue

establishment;

5. A clause guaranteeing the competent authority or

authorities the right to inspect the activities of the third country

supplier, including on-site inspections, should it wish to do so as part

of its inspection of the importing tissue establishment. The clause

should also guarantee the importing tissue establishment the right to

regularly audit its third country supplier;

6. The agreed conditions to be met for the transport of tissues

and cells between the third country supplier and importing tissue

establishment;

7. A clause ensuring that donor records relating to imported

tissues and cells are kept by the third country supplier or its sub-

contractor, in line with EU data protection rules, for 30 years

following procurement and that suitable provision is made for their

retention should the third country supplier cease to operate;

8. Provisions for the regular review and, where necessary,

revision of the written agreement including in order to reflect any

changes in the requirements of the EU quality and safety standards

laid out in Tissues and Cells (Quality and Safety) Regulations;

9. A list of all standard operating procedures of the third

country supplier relating to the quality and safety of imported tissues

and cells and a commitment to provide these on request.

€1.17

Before carrying out any activity, importing tissue

establishments shall apply for accreditation, designation,

authorisation or licence by

(a)

providing to the Authority the required information

and documentation as set out in Schedule I; and

(b) make available and, when requested by the

Authority, provide the documentation listed in Schedule III.

Importing tissue establishments shall take all measures in Measures to be

order to ensure that any imports of tissues and cells meet the taken

importing tissue

standards and quality and that the imported tissues and cells can be establishments.

traced from the donor to the recipient and vice versa.

(1) The importing tissue establishments shall not Duties of

undertake any substantial changes, such as changes to the types of importing

establishments.

imported tissues and cells and activities undertaken in third countries

which may have an influence on the quality and safety of imported

tissues and cells or the third party suppliers, without the prior written

approval of the Authority.

(2) When an importing tissue establishment undertakes a one-

off import of tissues or cells originating from a third country supplier

not covered by its existing accreditation, designation, authorisation or

licence, such an import shall not be considered as a substantial change

if the importing tissue establishment is authorised to import the same

type of tissues and cells from another country supplier or suppliers.

(3) The importing tissue establishment shall inform the

Authority in the case it ceases its import activities in full or in part.

(4) The importing tissue establishment shall notify without

delay the Authority of any suspected or actual serious adverse event

or reactions reported to them by third country suppliers which may

influence the quality and safety of the tissues and cells they import.

Such notification shall also include the information set out in

Schedules III and IV of the Human Tissues and Cells (Coding, S.L. 483.04

Processing, Preservation, Storage and Distribution) Regulations.

(5) The importing tissue establishment shall, without delay,

notify the competent authority of

(a)

any revocation or suspension, in whole or in part, of

a third country supplier authorisation to export tissues and cells;

and

(b) any other decision taken for reasons of non-

compliance by the competent authority of the country in which

the third country supplier is based and which may be relevant to

the quality and safety of the imported tissues and cells.

(1) The importing tissue establishment shall enter into

written agreement with the third country supplier where any of the

activities of donation, procurement, testing, processing, preservation,

storage or export to Malta of tissues and cells to be imported into

Malta are carried out outside of the Union

Provided that, where the importing tissue establishment

decides not to enter into a written agreement with the third country

supplier in the case of one-off imports, the said importing tissue

establishment shall ensure that suitable national measures are in place

to regulate such imports and that such national measures ensure

(a)

traceability from donor to recipient and vice versa;

and

(b) imported tissues and cells are not applied to anyone

other than their intended recipients.

(2) The written agreement referred to in sub-article (1) shall

specify

(a)

the quality and safety requirements to be met to

ensure the quality and safety standards of the tissues and cells to

be imported;

(b)

the contents listed in Schedule IV; and

(c)

the right of the Authority to inspect the activities

including the facilities of any third country supplier during the

duration of the written agreement and for a period of two years

following its termination.

(3) The importing tissue establishment shall provide copies of

such written agreement to the Authority, together with the application

for accreditation, designation, authorisation or licence provided for

under regulation 5.

(1) The importing tissue establishments shall keep a

record of their activities, including, but not limited to, the types and

quantities of tissues and cells imported, and on their origin and

destination. This record shall also include the same information for

any one-off imports carried out. The annual report shall include the

information provided for under regulation 7 of the Tissues and Cells

(Quality and Safety) Regulations.

(2) The Authority shall include the importing tissue

establishment in the publicly accessible register of tissue

establishments laid down in Article 10(2) of Directive 2004/23/EC.

(3) Information on the accreditations, designations,

authorisations or licence of importing tissue establishment shall also

be made available through the network of the registers referred to in

Article 10(3) of Directive 2004/23/EC.

Postal address of the site of reception (if different).

B. Contact Details for the Application

1. Name of contact person for the application.

2. Telephone number.

3. E-mail address.

4. Name of Responsible Person (if different from contact

person).

5. Telephone number.

6. E-mail address.

7. URL of ITE website (if available).

C. Details of Tissues and Cells to be Imported

1. A list of the types of tissues and cells to be imported,

including one-off imports of specific types of tissues or cells.

2. The product name (where applicable, in accordance with

the EU generic list) of all types of tissues and cells to be imported.

3. The trade name (if different to the product name) of all

types of tissues and cells to be imported.

4. The name of the third country supplier for each type of

tissue and cell to be imported.

D. Location of Activities

1. A list specifying which of the activities of donation,

procurement, testing, processing, preservation or storage are carried

out prior to import by the third country supplier per type of tissue or

cell.

2. A list specifying which of the activities of donation,

procurement, testing, processing, preservation or storage are carried

out prior to import by sub-contractors of the third country supplier per

type of tissue or cell.

3. A list of all activities carried out by the ITE subsequent to

import per type of tissue or cell.

4. The names of the third countries in which the activities

prior to import take place per type of tissue or cell.

E. Details of Third Country Suppliers

1. Name of third country supplier(s) (company name).

2. Name of contact person.

3. Visiting address.

4. Postal address (if different).

5. Telephone number including international dialling code.

6. Emergency contact number (if different).

7. E-mail address.

F. Documentation to Accompany the Application

1. A copy of the written agreement with the third country

supplier(s).

2. A detailed description of the flow of imported tissues and

cells from their procurement to their reception at the importing tissue

establishment.

3. A copy of the third country supplier’s export authorisation

certificate or, where a specific export authorisation certificate is not

issued, certification from the relevant third country competent

authority or authorities authorising the third country supplier's

activities in the tissue and cells sector including exports. This

documentation shall also include the contact details of the third

country competent authority or authorities. In third countries where

such documentation is not available, alternative forms of

documentation shall be provided such as reports of audits of the third

country supplier.