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Thursday, August 26, 2021

Investing in the pharmaceutical industry

 

Investing in the pharmaceutical industry in algeria

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:

pharmaceutical establishment for manufacturing and how to process it

 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.




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