, identifying the objectives, dates of implementation, autonomous communities in which it is to be carried out, as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the description.

2. The umbilical cord blood banks for autologous or family use, the intermediary companies of these banks or the insurance companies working with these banks or the intermediary companies must submit together with their request for authorization the following documentation:

(a) Copy of the statutes and corporate documents of the commercial company, cord blood bank or other legal personification of the umbilical cord blood units.

b) Simple copy of the registration certificate in the corresponding record.

(c) Fehaciente accreditation of the legal representation of the intermediary undertaking, in the event that the umbilical cord blood bank acts through it.

d) A certified copy of the agreement signed with the centers for obtaining cord blood as well as the authorization of such centers for the performance of the activity.

e) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities where it is to be carried out, as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the specification.

3. Entities for the collection of donors of haematopoietic progenitors of bone marrow or peripheral blood shall submit together with their application for authorisation the following documentation:

(a) Copy of the company's statutes and corporate documents, foundation or entity for the purpose of promotion and promotion of the donation, donor recruitment center or other legal personification for the realization of the Activities identified.

b) Simple copy of the registration certificate in the corresponding record.

c) A description of the company, foundation or entity in which its mission and objectives are collected.

d) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities in which it is to be carried out, as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the description.

4. The centres or entities promoting the donation of gametes shall submit, together with their application for authorisation, the following documentation:

(a) Copy of the company's statutes and corporate documents, foundation or entity for the purpose of promotion and promotion of the donation, donor recruitment center or other legal personification for the realization of the Activities identified.

b) Simple copy of the registration certificate in the corresponding record.

c) A certified copy of the agreement signed with the centers for obtaining gametes, in the event that it is not the same procurement center that performs the promotion, as well as the authorization of such centers for the realization of the cited activity.

d) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities in which it is to be carried out, as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support will be attached to this descriptive memory.

5. In cases where they are not covered by the above paragraphs, the parties concerned must submit the following documentation with their application for authorisation:

a) Copy of the statutes and corporate documents of the association of patients, society, foundation or entity for the purpose of promoting and promoting the donation.

b) Simple copy of the registration certificate in the corresponding record.

c) The descriptive memory of the association of patients, society, foundation or entity in which their mission and objectives are collected.

d) The description of the activity for which authorization is requested, identifying the objectives, dates of implementation, autonomous communities in which it is to be carried out, as well as the financial resources affected by the development of the activity. In the event that any type of documentary or audiovisual support is to be used, this support shall be attached to the description.

6. In the event of non-substantial modifications to the documentary or audiovisual media after the granting of the authorisation, those amendments shall be communicated within seven calendar days. since the modification is introduced, to the administrative authority that granted the authorization.

Article 4. Requirements for obtaining authorization.

1. For the purpose of granting the requested authorisation, the National Transplant Organisation shall take into consideration the following:

a) In the case of donation and/or donor recruitment campaigns:

1. The campaigns in favor of donation will be in accordance with the principles of voluntariness, altruism and disinterest, and must warn that neither the donor nor any other natural or legal person can request, or perceive, economic consideration or remuneration related to the object of this paragraph.

2. The promotion and publicity of the donation or procurement of tissues will in any case be carried out in a general way, without seeking benefit for specific people, and must avoid the collective calls for the donation in favor of a concrete patient.

3. The content of advertising and information to citizens in general and donors in particular will not be false or misleading and will be based on scientific evidence.

(b) In the event that the promotion or advertising includes sampling for typing or analysis, the applicant shall submit a responsible statement stating under his responsibility that such activity shall be carried out in compliance with the any time with the requirements established by the current regulations, in accordance with the provisions of Law 15/1999, of 13 December, of Protection of Personal Data, by Royal Decree 1720/2007, of 21 December, for which the approves the Regulation on the development of the Organic Law 15/1999 of 13 December on the protection ications may also be submitted by electronic means through the said paragraph.

Article 3. Documents to attach to the request.

1. The associations of patients or entities for the promotion and promotion of the donation of human tissues and cells shall submit, together with their application for authorisation, the following documentation:

a) Copy of the statutes and corporate documents of the association of patients, society, foundation or entity for the purpose of promoting and promoting the donation.

b) Simple copy of the registration certificate in the corresponding record.

c) The descriptive memory of the association of patients, society, foundation or entity in which their mission and objectives are collected.

d) The description of the activity for which authorization is requestedof personal data, as well as by Royal Decree 65/2006 of 30 January 2006 laying down requirements for the import and export of biological samples.

c) In the case of donation of gametes:

1. It will be demonstrated that any advertising or promotion activity by authorized centers that encourage the donation of human tissues and cells must respect the altruistic character of that, not being able, in any Case, encourage donation by offering compensation or economic benefits.

2. In the process of promotion and advertising, it will be specified that the donation will be anonymous and that the confidentiality of the identity of the donors by the banks of gametes, as well as, if necessary, by the the donor and activity records of the centres that are being set up.

2. The failure to comply with the current regulations, the entry of data not adjusted to the reality as well as the inadequacy of the planned actions to the objectives of strategic planning of the autonomous communities and the Ministry of Health, Social Services and Equality, both in the application and in the documentation provided, will lead to the refusal of authorisation.

Article 5. Procedure instruction and resolution.

1. The National Transplant Organisation shall, in accordance with Article 4, examine the content of the application for authorisation submitted. If the application does not meet the necessary requirements, the person concerned shall be required to do so within 10 days of the date of the notification and in accordance with Article 71 of Law No 30/1992 of 26 November 1992. (a) remedy the misconduct or accompany the required documents, with the indication that, if he does not do so, he or she shall be given the withdrawal of his or her petition, upon a decision given in accordance with Article 42 of that law.

2. Once the criteria referred to in Article 4 have been applied to the application, the National Transplant Organisation shall draw up the relevant motion for a resolution which, if favourable to the granting of the authority, you must specify the time period to which it is circumscribed. The motion for a resolution shall be submitted to the hearing of the persons concerned, who may, within a period of 15 days, plead and present the documents and justifications they deem relevant.

3. After the hearing, the National Transplant Organization will send a copy of the motion for a resolution to the Secretariat of the Transplant Commission of the Interterritorial Council of the National Health System for the purpose of The aforementioned joint body is issued with a report prior to the adoption of the relevant resolution.

4. The Director of the National Transplant Organization will issue a resolution that will be motivated in the cases provided for in Law 30/1992, of November 26. The decision must be made and notified to the person concerned within the maximum period of three months from the date on which the application is lodged in the Register, without prejudice to the possibility of suspending the term of time by the circumstances. laid down in Article 42 (5) of Law 30/1992 of 26 November 1992 and the extension of the maximum period provided for in paragraph 6 of the same provision.

5. As provided for in Article 43 of Law No 30/1992 of 26 November 1992, the expiry of the maximum period without having been notified to the interested party in order to understand his application is legitimate. Accordingly, the person concerned may, from the date of expiry of that maximum period, assert the estimate produced by administrative silence.

6. The decision of the Director of the National Transplant Organization puts an end to the administrative route, in accordance with Article 9.3 of the Statute of the National Transplantation Organization, approved by Royal Decree 1825/2009, 27 November. Consequently, that decision, in accordance with Articles 116 and 117 of Law No 30/1992 of 26 November 1992, may be challenged directly in the context of the judicial or administrative judicial order, or may be contested in the replacement to the same organ as the one.

7. The resolutions issued by the Director of the National Transplant Organization as provided for in this royal decree will be communicated to the affected autonomous communities.

Article 6. Revocation of the authorization.

The failure to observe the actions of the authorized entity as required by the current rules of application, as well as of what is stated in the corresponding application, will result in the revocation of the authorization granted. For such purposes, the National Transplant Organisation shall proceed on its own initiative in accordance with the procedure laid down in the previous Article.

Single additional disposition. No increase in public spending.

The forecasts contained in this royal decree will not entail an increase in public expenditure and will be carried out with the material, technical and personal means available without any modification or increase of allocations and remuneration.

Single repeal provision. Regulatory repeal.

All provisions of equal or lower rank are repealed to be opposed to the provisions of this royal decree.

Final disposition first. Competence title.

This royal decree is dictated by the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence on the basis and general coordination of health.

Final disposition second. References to Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

The references contained in this royal decree to Law 30/1992, of November 26, will be construed as references to Law 39/2015 of 1 October of the Common Administrative Procedure of the Public Administrations at the time of their entry into force.

Final disposition third. Development and execution faculty.

The head of the Ministry of Health, Social Services and Equality is empowered to make the necessary provisions for the development and implementation of this royal decree, as well as to adapt the annexes to the legislation.

i) the Community or the Member States of the European Community;

Final disposition fourth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Palma de Mallorca, on August 5, 2016.

FELIPE R.

The Minister of Health, Social Services and Equality,

ALFONSO ALONSO ARANEGUI

ANNEX I

ANNEX II

ANNEX III

ANNEX IV

ANNEX V