Authorisation of entities for the distribution of medicines for human use.

Authorisation of entities for the distribution of medicinal products for human use: wholesale warehouses and contract warehouses.

NEW ELECTRONIC SUBMISSION How to submit electronically?

Regional ministry: Consejeria De Salud
Governing board: Direc. General De Farmacia, Humanizacion Y Coordinacion Sociosanitaria (DIR3: A06029672)
Classification: Authorizations, licenses, concessions and approvals
Subject(s): Health
Starting way: Interested
Target: Citizens; Legal entities, self-employed persons and registered professionals
Subject to fees: Yes
Fees
Languages in which the procedure can be completed: Spanish.
Allow power of attorney: Yes
Links to web pages with specific information
Type

Requirements: Wholesale warehouses and, where appropriate, pharmaceutical laboratories that directly distribute their products will be obliged to:
a) To have premises and equipment equipped with personal, material and technical means to guarantee the correct conservation and distribution of medicines, with full guarantees for public health.
b) To guarantee compliance with the general or particular conditions for the storage of medicinal products and especially the maintenance of the cold chain throughout the distribution network by means of standardised procedures.
c) Maintain minimum stocks of medicines to ensure adequate continuity of supply.
d) Ensure delivery times, minimum frequency of deliveries, permanent pharmaceutical technical advice and means of support for pharmacies and offices.
e) To carry out on-call and disaster prevention services.
f) Have an emergency plan that guarantees the effective application of any withdrawal from the market ordered by the competent health authorities.
g) To have implemented an alert system that covers all pharmacies in the territory within its scope of action.
h) Comply with the standards of good distribution practices that have been promoted or authorised by the competent health administrations and to collaborate with them to ensure quality pharmaceutical provision.
i) To comply with other obligations imposed by law or regulation.

Deadline for submission

All year round.

Submission deadline start date

27/02/2007

Submission deadline end date

Periodicity

Continuous

Means of submission

Telematic

Online submission: At the General Electronic Registry; Art. 14. 2 of the Law 39/2015, of 1 October, of the Common Administrative Procedure of the Public Administrations, establishes the obligatory nature of the electronic management for certain subjects as, for example, a) The juridical persons, b) Entities without legal personality, c) Those who carry out a professional activity for which compulsory membership is required, for the procedures and actions they carry out with the Public Administrations in the exercise of said professional activity. In any case, within this group, notaries and property and mercantile registrars shall be included. d) Those who represent an interested party who is obliged to relate electronically with the Administration, e) The employees of the Public Administrations for the procedures and actions that they carry out with them due to their condition of public employee, in the form in which it is determined by regulation by each Administration.

Annex 1. Documentation authorisation of a wholesale distribution warehouse. List of documents to be submitted for the application for authorisation as a wholesale warehouse for the distribution of medicines. Mandatory Annex I wholesale warehouse authorisation documentation v.3
Annex 2. Third-party warehouse document or contract for medicines for human use. List of documents to be submitted for the application for authorisation of a third-party warehouse or by contract for medicines for human use. Mandatory Annex II warehouse authorisation documentation by contract v.3

Instructor board: Pharmaceutical Planning Section.
Attributive rule: Decree 54/2023, of 20 July, partially modifying the Basic Organic Structure of the Ministries of the Government of Cantabria.
Reports or opinions: No reports or opinions are required
Resolution entity: General Director of Pharmacy, Humanization and Social and Health Coordination.
Attributive rule: Decree 54/2023, of 20 July, partially modifying the Basic Organic Structure of the Ministries of the Government of Cantabria.
Maximum deadline for decision: 90 Business days
Average deadline for decision: 60 Business days
Effects of the administrative silence or inactivity of the Administration
Does it put an end to the administrative procedure?: No
Subject to participation of certification partner entities: No
Certification Partner Entities: Currently, there are no certification partner entities authorized to act in this procedure.

Type: Appeal.
Board: Health Counselor
Deadline: 1 month if the resolution is express; if it is not, at any time from the day following the day on which, in accordance with its specific regulations, the effects of administrative silence occur.

Regulation applied: Law of Cantabria 5/2018, of 22 November, on the Legal Regime of the Government, the Administration and the Institutional Public Sector of the Autonomous Community of Cantabria.; Royal Legislative Decree 1/2015, of 24 July, approving the revised text of the Law on guarantees and rational use of medicines and medical devices.; Royal Decree 782/2013, of 11 October, on the distribution of medicines for human use.

Submission

NEW ELECTRONIC SUBMISSION How to submit electronically?

The 012 General Telephone Information Service will be available 24 hours a day, every day of the year, according to the following timetable:

Personal telephone attention by means of information agents, from 9:00 to 21:00 hours from Monday to Friday, excluding public holidays.
Mechanised attention, via voicemail, during other hours and on public holidays.
Incoming calls to the mailbox will be recorded and then, from the General Information Telephone 012, a response call will be made to the citizen to resolve his or her request for information.
For telephone calls from outside the Autonomous Community of Cantabria you can dial 942 395 563 (from abroad +34 942 395 563); if you are calling from Cantabria, you can dial 942 395 562.
This service is only available in Spanish.