The pharmaceutical institution for industrialization in Algeria and the modalities of handling the file
The opening of a pharmaceutical establishment for the
manufacture of pharmaceutical substances or medical supplies for use in human
medicine must be subject to a prior approval of completion allowing the
acquisition of equipment and materials necessary to launch a project, as well
as the approval of the opening, delivered by the Minister in charge of the
pharmaceutical industr.y
Chapter One:
Elements of a pre-approval application file for the completion of a pharmaceutical establishment for manufacturing and the methods of its treatment.
The
application for pre-accreditation for the completion of a pharmaceutical
establishment for manufacturing shall be deposited, by the pharmacist, its
technical director, with the competent departments of the Ministry in charge of
the pharmaceutical industry, in accordance with the approval application form
prepared for this purpose, by the competent departments of the Ministry in
charge of the pharmaceutical industr.y
1The application for pre-accreditation for the establishment of a pharmaceutical establishment for manufacturing shall be attached to a file that includes:
Pre-accreditation application form for the
establishment of a pharmaceutical manufacturing establishment:
-A copy of the
basic law of the pharmaceutical institution,
-A copy of the commercial register,
- The work
contract of the pharmacist technical director,
-property
contract or lease agreement,
- Layout of the entire pharmaceutical establishment
with a scale of 1/100 with the layout and allocation of stores,
-Scheme that
specifies the location of major equipment,
-Detailed scheme
of air and water treatment systems,
-Plans defining the flows of people, raw materials,
packaging materials, intermediate products, finished products and wastes
related to pharmaceutical operations,
-Description of
the quality system of the pharmaceutical establishment,
-Describe the
type and organization of quality control,
-Description of
the means available to avoid cross-contamination transmission,
-Perceived
pharmacological processes,
-List of production and quality control equipment,
-List of different dosage forms of drugs or classes
of medical supplies,
-The assortment of products expressed by the
international designation of pharmaceutical products or by the designation of
medical supplies, as well as the expected annual production quantities and
production capacities expressed in sales units,
-Technical support for technology transfer agreements,
when require,
-Handling
contract, if applicable,
-A list of the
pharmaceutical operations concerned with the activities and the conditions for
their implementation in the case of external activities,
-The detailed
composition of the pharmaceutical establishment, showing all the places of
manufacture and storage of gases in fixed tanks or in bottles and similar
containers for gases for medical use,
-Identification of radioactive drugs by type (radioactive drugs and radioactive
drugs Buzatronah precursors of radioactive destined for production and
generators radionuclides), and the method of risk management, radiation
protection and supporting documents to the competence of the technical director
of radiation protection and licensing of energy province atomic for radioactive
drugs,
-The status of the progress of the achievement in the case of a request to renew the pre-accreditation for completion,
-The file deposit receipt is delivered to the
requesting pharmaceutical institution,
2/Only files
of a pre-approval application for the completion of a pharmaceutical
establishment for manufacturing, which are considered complete, shall be
accepted by the competent departments of the Ministry in charge of the
pharmaceutical industry
-The
file is studied to request pre-accreditation for completion, and it is
presented to a technical evaluation carried out by experts at the request of
the competent departments of the Ministry in charge of the pharmaceutical
industry. Experts must submit technical evaluation reports within ten (10)
days,
The file attached to the evaluation reports of the requesting pharmaceutical institution’s accreditation file shall be presented to the technical committee established by the Minister in charge of the pharmaceutical industry. The technical committee and the experts mentioned in the above paragraph can request supplementary information,
The technical committee can, if necessary,
seek the assistance of any natural or legal person who has competencies and
qualifications in the field who can assist it in its work. The composition,
organization and functioning of the technical committee, as well as the list of
experts, are determined by a decision of the Minister in charge of the
pharmaceutical industry,
3/The
Technical Committee meets in a regular session every fifteen (15) days, and in
an extraordinary session whenever necessary to study all requests for
accreditation of pharmaceutical establishments for manufacturing, as well as
renewal requests related to accreditation of a pharmaceutical establishment for
manufacturing,
The
Technical Committee is available for a period of eight (8) days to give its
opinion on the accreditation application. It ensures that the information
provided in accordance with the provisions of the above article is correct and
complies with the rules of good manufacturing practices and the applicable
regulatory provisions,
In the event of examining reservations related to the
technical evaluation of the file, the requesting pharmaceutical institution
shall be notified, within a period of eight (8) days, by the concerned party in
the pharmaceutical industry,
The applicant is obligated to lift these reservations
within a period not exceeding sixty (60) days, after which he can submit a
justified extension request that can be approved by the competent departments
of the Ministry in charge of the pharmaceutical industry,
At the end of the evaluation of the technical
committee mentioned in the first paragraph above, and in the event that the
file is considered complete, it shall be notified to the requesting
pharmaceutical institution for pre-accreditation, for prior approval,
The
Minister in charge of the pharmaceutical industry has the right to wrap the
pre-approval request within thirty (30) days to decide on the completion of the
pharmaceutical establishment,
The decision of the Minister in charge of the
pharmaceutical industry shall be notified to the Indicative of the student,
4/The
pre-approval for the completion of the pharmaceutical establishment for
industrialization stipulates, in particular,
-Company name
and manufacturing location address,
-Approved
pharmaceutical manufacturing processes,
-List of
approved pharmaceutical forms for manufacture,
-Appointment
according to the nature of pharmaceutical substances approved for manufacture,
-Appointment according to the therapeutic class of drugs approved for manufacture-Technical director practice course reference,
-The
pre-approval for implementation is delivered by the Minister in charge of the
pharmaceutical industry for a period of one (1) year, subject to renewal,
-In order to
renew the pre-accreditation for completion, the student must deposit a progress
status of his project. The Minister in charge of the pharmaceutical industry
may refuse to renew the pre-accreditation for the completion if the case of
progress at the end of its validity period and after its renewal is not
justified.
Chapter II
Elements of the application file for accreditation to open a pharmaceutical establishment for manufacturing and how to process it:
1/At the end
of the completion of the project, the pharmaceutical establishment for
manufacturing must submit an application for accreditation to open a
pharmaceutical manufacturing establishment by the pharmacist, its technical
director, with the competent authorities of the Ministry in charge of the
pharmaceutical industry.
The application for approval to open a pharmaceutical establishment for manufacturing shall be attached to a file that includes, in addition to the elements mentioned in the above article
-Application form for approval to open a
pharmaceutical manufacturing establishment prepared for this purpose by the
competent departments of the Ministry in charge of the pharmaceutical industry,
-the
exploitation license for a classified enterprise, which is handed over to the
competent departments of the Ministry in charge of the environment,
-The opinion
of conformity with the security standards prepared by the civil protection
services,
-A document related to the conditions of building
insurance and pharmaceutical documentation,
-A document
related to the quality risk management process,
-The expected
organizational chart that reflects the organization of the pharmaceutical
institution and which shows the main positions of responsibility and the
schedule of the number of users as well as their qualifications,
-Receipt of
payment of the fee related to the experience request to the pharmaceutical
institution. The file deposit receipt is delivered to the requesting
pharmaceutical institution,
2/Only files
of accreditation request for opening a pharmaceutical manufacturing
establishment, which are considered complete, shall be accepted by the
competent departments of the Ministry in charge of the pharmaceutical industry.
The
application file for accreditation is subject to study and presented to a
technical evaluation in accordance with the provisions of the first chapter
above, in addition to the experience of the manufacturing site carried out by
experts at the request of the competent departments of the Ministry in charge
of the pharmaceutical industry and at the request of the pharmaceutical
institution requesting approval of the opening. Experts must submit technical
evaluation reports within ten (10) days.
The file
shall be attached to the technical and experience evaluation reports that were
made on the website of the requesting pharmaceutical institution and presented
to the technical committee stipulated in the above article.
The technical
committee and the experts mentioned in the above paragraph may request
supplementary information. The technical committee may, if necessary, seek the
assistance of any natural or legal person who has the qualifications and
qualifications in the field who can assist it in its work.
3/The
technical committee is available within eight (8) days to give its opinion on
the accreditation request. It ensures that the information provided in
accordance with the provisions of the above article is correct and complies
with the rules of good manufacturing practices and the applicable regulatory
provisions.
In the event of examining reservations related to the
technical evaluation of the file and/or the site’s experience, the requesting
pharmaceutical institution shall notify the pharmaceutical industry within
eight (8) days of the concerned departments from the concerned party. The
student must lift these reservations within a period not exceeding sixty (60)
days, after which he can submit a justified extension request that can be
approved by the competent departments of the Ministry in charge of the
pharmaceutical industry.
At the end of the evaluation of the technical
committee mentioned in the first paragraph above, and in the event that the
file is considered complete, the requesting pharmaceutical institution to
approve the opening is notified of the acceptance of the file.
The
Minister in charge of the pharmaceutical industry has a period of thirty (30)
days to decide on the application file for the approval of opening a
pharmaceutical establishment.
The decision of the Minister in charge of the
pharmaceutical industry shall be notified to the requesting pharmaceutical
institution.
4The approval for opening a pharmaceutical
establishment for manufacturing must contain the data mentioned in the above
article.
The
approval for the opening of a pharmaceutical manufacturing establishment for a
period of five (5) years, subject to renewal, is delivered by the Minister in
charge of the pharmaceutical industry without prejudice to the provisions of
Article 11 of the Executive Decree No. 21-82 of Rajab 1442 corresponding to
February 23, 2021 and the aforementioned.
In order to renew the opening accreditation, the
student must deposit the site experience request with the competent departments
of the Ministry in charge of the pharmaceutical industry.
Chapter III
Substantial modifications that have an impact on pharmaceutical manufacturing processes
1/Amendments of a fundamental nature are considered major modifications that have
an impact on the pharmaceutical manufacturing processes of an approved
pharmaceutical institution. These fundamental modifications require the
granting of a prior license from the Minister in charge of the pharmaceutical
industry after taking the opinion of the technical committee mentioned in the
above article, in accordance with the provisions of the applicable regulation.
The list of material amendments includes, in particular
-Manufacture of a new class of pharmaceutical
materials,
-Manufacture
of a new category of medical supplies,
-Manufacture
of a new pharmaceutical form,
-Manufacture
of a new therapeutic class,
-Manufacture of medicines containing active ingredients of real danger,
-Implementation
of a new pharmaceutical manufacturing process,
-Completion or
expansion of new buildings in which pharmaceutical operations are carried out,
-Cancellation of
stores where production and/or quality control operations are carried out,
-Air or water
treatment system design.
2/The pharmaceutical
institution that obtained the approval of the Conquest shall submit to the
Minister in charge of the pharmaceutical industry, for evaluation and
licensing, every amendment of a substantial nature. Substantial modifications
are evaluated and a license is granted. Advance notice within a period not
exceeding thirty (30) days.
The
pharmaceutical institution that obtained the opening approval is obligated to
also inform the Minister in charge of the pharmaceutical industry, within a
period not exceeding fifteen (15) days, of any amendment to the data mentioned
in the approval decision, as well as all other amendments, in particular.
-Changing the
company’s trade name,
-Changing the
legal nature of the pharmaceutical manufacturing establishment,
-Relocation of the headquarters of the Pharmaceutical
Manufacturing Corporation,
-Appointing a
new technical director within a period not exceeding fifteen (15) days from the
resignation of the previous technical director,
-cessation of a
pharmaceutical activity or process,
-Manufacturer's
list.