Pharmaceutical Manufacturing Licensing Service

The pharmaceutical manufacturing licensing service plays a pivotal role in assisting businesses with critical legal procedures. Pharmaceutical production operations require enterprises to meet stringent conditions regarding facilities, technology, and personnel. Long Phan Consulting Company offers professional consulting, supports dossier preparation, and undertakes authorization for clients. This article provides a detailed analysis of the pharmaceutical manufacturing licensing service according to current regulations.

Current Licensing Process for Drugs, Pharmaceutical Chemicals, and Medicinal Materials

The drug manufacturing licensing process is stipulated in Article 38 of the Drug Law 2016 and its guiding documents. Pharmaceutical manufacturers must adhere to strict Good Manufacturing Practices (GMP) conditions. The procedure for issuing a pharmaceutical manufacturing license includes an assessment of facilities, technology, and personnel against international standards. This pharmaceutical manufacturing licensing service is essential for compliance.

Components of a Pharmaceutical Manufacturing License Dossier

A dossier for a Certificate of Eligibility for Pharmaceutical Business includes:

• An application for a Certificate of Eligibility for Pharmaceutical Business (standard form).
• A copy of the Certificate of Business Registration or Establishment Decision.
• A detailed description of pharmaceutical business facilities and technology.
• A detailed layout diagram of the facility.
• A list of main equipment for business operations.
• Copies of diplomas and certificates of the person professionally responsible for pharmaceuticals.
• Operating and quality management procedures. Long Phan Consulting Company ensures your pharmaceutical manufacturing licensing service dossier is complete.

Receiving and Processing Authority

As per Clause 1, Article 37 of the Drug Law 2016 (Note: The original text mentions Drug Law 2017 for this clause, but Article 37 concerns advertising information, and Article 32, 33 of Drug Law 2016 seems more relevant for licensing authority. Assuming a slight typo and referring to the general authority for pharmaceutical business licensing which is the Ministry of Health), the Minister of Health is responsible for receiving and processing dossiers for the pharmaceutical manufacturing license for drugs, pharmaceutical chemicals, and medicinal materials. The processing time is not to exceed 30 working days from the receipt of a complete and valid dossier, as regulated by Decree 54/2017/ND-CP and Decree 155/2018/ND-CP.

Licensing Implementation Process

The pharmaceutical manufacturing licensing service follows these steps:

• Step 1: Dossier Submission Organizations requiring a Certificate of Eligibility for Pharmaceutical Business submit their dossiers to the competent licensing authority.
• Step 2: Dossier Appraisal Within 30 days of receiving a complete application, the Minister of Health organizes an evaluation and issues the Certificate of Eligibility for Pharmaceutical Business if conditions are met. If not issued, a written response stating the reasons is provided. The licensing authority conducts an on-site inspection of the enterprise’s facilities, technology, and personnel. This inspection is performed by an Inspection Council established by the licensing body, comprising experts with pharmaceutical qualifications. Inspection results are recorded in minutes and form the basis for the authority’s decision.
• Step 3: Result Reception The organization receives the results from the competent authority.

Note: If re-issuance is due to an error by the issuing agency, the applicant submits a dossier as per regulations. The re-issuance timeframe is 07 working days from receiving a complete dossier. This detailed process is part of our comprehensive pharmaceutical manufacturing licensing service.

>>> See more: Pharmacy Business License: Conditions & Application Procedures

Consulting Services for Pharmaceutical Manufacturing Licensing at Long Phan Consulting Company

Long Phan Consulting Company delivers a professional pharmaceutical manufacturing licensing service with a team of experienced specialists. Our consulting services strictly adhere to regulations. Clients receive comprehensive support from initial consultation until the completion of the pharmaceutical manufacturing license procedure.

Content of the Pharmaceutical Manufacturing Licensing Service for Drugs, Pharmaceutical Chemicals, and Medicinal Materials

Depending on client needs and service stage, we provide a pharmaceutical manufacturing licensing service with one or more of the following:

Expert Consultation on Pharmaceutical Manufacturing Licensing Conditions

Long Phan Consulting Company conducts a comprehensive analysis of mandatory legal conditions under the Drug Law 2016, Decree No. 54/2017/ND-CP (amended by Decree 155/2018/ND-CP), Decree No. 01/2021/ND-CP, and industry standards like Good Manufacturing Practices (GMP-WHO, GMP-EU). Based on this, we develop a tailored consultation plan for each business model and product type (pharmaceutical chemicals, medicinal drugs, traditional medicines…). Our pharmaceutical manufacturing licensing service is thorough.

Specifically, consultation focuses on three core groups of conditions:

• Conditions for physical facilities and technical equipment: Advice on layout structure, functional zoning in the manufacturing plant ensuring “one-way” principles and appropriate segregation between areas. Recommendations for equipment lists and environmental control systems for each dosage form, ensuring compliance with cleanliness, pressure, temperature, and humidity requirements per GMP.
• Conditions for personnel organization and professional qualifications: Guidance for businesses in building an appropriate organizational structure, clearly assigning functions and tasks for each department. Consultation on professional standards, qualifications, and experience of the professionally responsible pharmacist, as well as quality control, production, and storage teams, to meet the stringent requirements of the appraisal agency.
• Conditions for quality management systems and internal processes: Support in developing GMP-compliant documentation systems including: quality manuals, standard operating procedures (SOPs), batch manufacturing records, testing records, and deviation control systems – to ensure traceability and quality control throughout all production activities.

For each client, we provide a detailed plan and a personalized implementation roadmap, adjusted based on the actual status and capacity of the facility. This roadmap serves as a comprehensive legal and technical guide for the business. With an understanding of the procedural implementation, Long Phan Consulting Company confidently offers clients specialized consulting services such as:

• In-depth consultation on the licensing application procedure: Long Phan Consulting Company provides a detailed analysis of each step in the pharmaceutical manufacturing license application process as stipulated in Decree 54/2017/ND-CP and related guiding documents. We assist in accurately identifying the competent authority for dossier reception corresponding to each locality or type of manufacturing facility. Our experts provide thorough advice on legal timelines to adhere to, the on-site facility appraisal process, and how to prepare for pre-licensing condition checks.
• In-depth consultation on personnel utilization plans: We develop a roadmap for arranging specialized personnel consistent with legal requirements for the professionally responsible person under the Drug Law and GMP standards. Long Phan Consulting Company assesses and recommends mandatory positions such as: Pharmacist in charge, Head of Production, Head of Quality Control, and Head of Quality Assurance. We also assist in determining an appropriate personnel structure, planning training, completing professional competency dossiers, and ensuring personnel meet qualification, experience, and working time requirements as per regulatory agency demands. This is a key component of our pharmaceutical manufacturing licensing service.
• Consultation on effective operational plans: Long Phan Consulting Company partners with businesses to build a GMP-compliant operational management model for pharmaceutical manufacturing facilities, aiming for stability, efficiency, and legal compliance. We support the development of functional zoning diagrams and material flow processes (raw materials – semi-finished products – finished products) within the facility, ensuring strict control from input to output. We also provide recommendations for improving production processes, quality management, and equipment maintenance to reduce operational costs while maintaining technical standards and product quality. Long Phan Consulting Company guides the application of suitable management software for GMP record storage, retrieval, and to meet inspection requirements from authorities quickly and transparently.

Preparation and Completion of Licensing Dossiers According to Current Legal Standards

The quality of the legal dossier is a key factor determining licensing efficiency. Long Phan Consulting Company offers services for drafting, verifying, and completing the entire pharmaceutical manufacturing license dossier in strict accordance with Ministry of Health requirements and related guiding documents, particularly Circular No. 01/2021/TT-BKHDT on forms and administrative procedures for registering conditional businesses. The pharmaceutical manufacturing licensing service ensures your dossier meets all standards.

Dossier contents include:

• Legal dossier components: Certificate of Business Registration, decision on establishment of the production unit (if any), personnel organization chart, labor contracts, and professional qualifications of technical and quality control managers.
• Technical and professional dossiers: Factory layout drawings, production line descriptions, standard operating procedures for each stage, list of equipment and quality control systems, finished product and raw material testing record systems.
• Quality management documents: Quality manual, personnel training records, incident handling and product recall procedures, production risk assessment reports.

The entire dossier undergoes a three-step expert review: Drafting – Editing – Internal Appraisal, before official submission. This strict control ensures accuracy, completeness, and a high chance of approval on the first submission, significantly shortening appraisal and licensing times. Our pharmaceutical manufacturing licensing service focuses on this efficiency.

Authorized Representation Throughout the Entire Licensing Process

To optimize work efficiency and help businesses save internal operational resources, Long Phan Consulting Company provides a comprehensive authorized representation service throughout the entire pharmaceutical manufacturing license application process. This service is implemented systematically, professionally, and ensures legality in every phase, including:

• Representing in dossier submission to competent authorities: Long Phan Consulting Company acts on behalf of clients to submit licensing dossiers to the Ministry of Health or provincial Departments of Health, depending on the jurisdiction for each type of facility and scope of production. We identify the correct receiving body, prepare dossiers according to standard forms, and ensure timely and compliant submission to avoid errors affecting processing timelines.
• Monitoring dossier processing progress and handling amendments: After submission, we closely monitor the processing status at the competent authority. Long Phan Consulting Company proactively communicates, updates on dossier appraisal progress, and promptly informs clients. If amendments, supplements, or clarifications are required, we quickly analyze the request, draft response letters, and handle all related procedures to ensure no interruption to the review process.
• Coordinating and supporting on-site inspections: When authorities conduct on-site appraisals, Long Phan Consulting Company directly coordinates with the inspection team to organize the inspection at the manufacturing facility. We assist in preparing dossiers for appraisal, arranging workspaces according to inspection procedures, coordinating technical personnel for the working session, and representing in explaining legal or technical content as needed. Our experts are ready to handle any arising situations, helping the inspection proceed smoothly and achieve good results. This support is integral to our pharmaceutical manufacturing licensing service.
• Receiving results and guiding subsequent steps: After appraisal completion and license issuance, Long Phan Consulting Company represents clients in receiving the Certificate of Eligibility for Pharmaceutical Manufacturing and hands it over. We also provide detailed guidance on the next steps businesses need to take, such as announcing eligibility for manufacturing on the Ministry of Health’s portal, registering drug label samples, or other declaration procedures so the facility can officially operate in compliance with the law.

All information regarding processing progress and legal status is updated promptly and transparently, helping clients control the implementation process proactively and effectively.

Process of Providing Pharmaceutical Manufacturing Licensing Consulting Services

The pharmaceutical manufacturing licensing service process at Long Phan Consulting Company is designed in a six-step roadmap, corresponding to important legal and technical stages in obtaining a Certificate of Eligibility for Pharmaceutical Manufacturing. Each step is performed by experienced legal and technical experts, ensuring efficiency, legal compliance, and maximum time savings for clients.

• Step 1: Information Reception and On-site Survey Upon receiving a request, Long Phan Consulting Company gathers preliminary information about the intended product type, the business’s legal status, current factory conditions, facilities, equipment systems, and personnel organization. Experts conduct an on-site survey at the production location to assess compliance with conditions stipulated in the Drug Law 2016 and Decree 54/2017/ND-CP. Based on survey results, we prepare a status assessment report and identify areas requiring in-depth consultation in subsequent steps.
• Step 2: Legal Condition Consultation and Implementation Roadmap Development From the survey results, Long Phan Consulting Company develops a comprehensive consultation plan. This includes a detailed analysis of mandatory legal conditions for pharmaceutical manufacturing facilities, such as factory area and layout, mandatory equipment lists, quality control systems, personnel standards, and standard operating procedures (SOPs). We establish a specific implementation roadmap, divided into clear phases with timelines, technical objectives, and corresponding legal tasks. This consultation helps businesses understand all necessary steps to meet licensing conditions as per current regulations. This proactive planning is a hallmark of our pharmaceutical manufacturing licensing service.
• Step 3: Guidance on Completing Actual Conditions of the Manufacturing Facility In this step, Long Phan Consulting Company partners with the business to renovate or upgrade the manufacturing facility according to GMP standards set by the Ministry of Health. We provide detailed support in adjusting layout diagrams, segregating production, storage, quality control, and sanitation areas based on one-way principles, ensuring hygiene conditions and preventing cross-contamination. Simultaneously, we advise on reorganizing the personnel structure, appointing qualified professionals as required by law, preparing internal inspection forms, and training records for appraisal readiness. If businesses need advice on equipment procurement or quality management software selection, we can introduce reputable specialized units and assist with technical input checks.
• Step 4: Drafting and Completing the Licensing Application Dossier After actual conditions are standardized, Long Phan Consulting Company drafts the entire pharmaceutical manufacturing license application dossier. The dossier includes legal documents (business registration, key personnel appointment decisions, professional personnel declarations), technical documents (factory layout drawings, technological line diagrams, equipment lists, quality control systems), and quality management documents (SOPs, batch manufacturing records, internal control systems). Each dossier is meticulously reviewed through multiple internal appraisal rounds to ensure completeness, accuracy, and compliance with complex requirements from the appraisal agency.
• Step 5: Representing Clients in Licensing Procedures with Competent Authorities Long Phan Consulting Company is officially authorized to represent clients in all licensing procedures with state agencies. This includes submitting dossiers to the Drug Administration of Vietnam or local Departments of Health, monitoring processing progress, addressing requests for amendments or supplements (if any), and coordinating on-site facility appraisals. During appraisal, we assist businesses in preparing records, training personnel for the inspection, explaining production and testing processes, and handling arising situations. After dossier approval, we receive and deliver the Certificate of Eligibility for Pharmaceutical Manufacturing to the business within the stipulated timeframe. Our representation streamlines the pharmaceutical manufacturing licensing service.
• Step 6: Post-Inspection Support and Long-Term Operational Condition Maintenance Beyond successful licensing, Long Phan Consulting Company continues to support clients during the post-inspection phase and in maintaining operational standards. We provide periodic advice on updating GMP dossiers, maintaining quality documentation systems, preparing periodic reports as required by regulatory agencies, and assisting with issues arising during production or unexpected inspections. If businesses need to adjust their production scope, renew licenses, change locations, or key personnel, we provide timely and accurate dossier update services according to current legal procedures.

Commitment to Service Quality and After-Sales Support Policy

Long Phan Consulting Company commits to providing a high-quality and expedited pharmaceutical manufacturing licensing service. We guarantee a 100% success rate for dossiers prepared according to strict standards. All consulting services are performed by experts with extensive experience in pharmaceuticals and law.

Service Quality Commitment

• Professional Commitment: Long Phan Consulting Company ensures all pharmaceutical manufacturing licensing service offerings are delivered by highly qualified legal and technical experts with many years of experience in the pharmaceutical sector. We are proficient in current legal regulations such as the Drug Law 2016, Decree 54/2017/ND-CP, and international technical standards like GMP-WHO. This guarantees all consulted dossiers are accurate in content, complete in form, and align with state management practices.
• Dossier Effectiveness Commitment: Each dossier undergoes a multi-round review process to ensure acceptance and approval by competent authorities from the first submission. We commit to a 100% success rate for dossiers completed under expert guidance. Dossiers are standardized based on actual forms, with content presented coherently, scientifically, and appropriately for each type of production.
• Timeline and Transparency Commitment: Long Phan Consulting Company establishes a clear implementation process with specific timelines, ensuring businesses understand the entire service delivery schedule. All time commitments are transparently stated in the contract. We proactively coordinate closely with licensing agencies to expedite processing, minimizing client waiting times while ensuring adherence to legal procedures.

After-Sales Support Policy

• Operational Condition Maintenance Support: After completing the licensing procedure, Long Phan Consulting Company continues to partner with clients to ensure businesses maintain full compliance with facility, personnel, and management process conditions according to GMP standards. We provide periodic advice on legal changes affecting pharmaceutical production and offer appropriate legal solutions for specific situations.
• Consultation on Overcoming Arising Legal Risks: Clients receive support in handling issues arising during production, such as inspections, requirements for additional technical conditions, or adjustments requested by regulatory agencies. Our expert team directly coordinates to review internal systems, propose reasonable handling measures, and protect the legal rights of the business in all situations.
• Services for Adjusting, Extending, and Expanding License Scope: Long Phan Consulting Company provides comprehensive post-licensing services such as renewal, content adjustment of the Certificate of Eligibility for Pharmaceutical Manufacturing; registration of additional production lines; expansion of operational scope, or relocation of production sites. Clients receive priority in implementation timelines and flexible service pricing policies, saving costs when using long-term or integrated multi-procedure services.
• Incentives for Loyal Clients: We have a dedicated incentive policy for clients using comprehensive service packages or returning for subsequent procedures. Benefits include service fee reductions, regular free legal consultation support, and periodic updates on new legal documents relevant to their business sector. Our pharmaceutical manufacturing licensing service aims for long-term partnerships.

Contact Information for Pharmaceutical Manufacturing Licensing Service for Drugs, Pharmaceutical Chemicals, and Medicinal Materials

For detailed consultation on the pharmaceutical manufacturing licensing service for drugs, pharmaceutical chemicals, and medicinal materials, please contact us:

• Head Office Address: TM7 Commercial Lot, Lavita Garden Apartment, 17 Street No. 3, Truong Tho Ward, Thu Duc City, Ho Chi Minh City
• Working Hours: Monday to Saturday – 8:00 AM to 5:30 PM
• Online Consultation Hotline: 1900.63.63.89
• Email: info@longphanpmt.com
• Zalo: 0906.735.386 – Long Phan
• Facebook: Long Phan Investment Consulting and Legal Services LLC

We commit to responding promptly to all consultation requests and providing support in the shortest possible time. The pharmaceutical manufacturing licensing service by Long Phan Consulting Company is flexibly designed to suit the diverse needs of each enterprise.

Reasons to Choose Consulting and Support Services for Licensing at Long Phan Consulting Company

Long Phan Consulting Company has a team of experts with extensive experience in the pharmaceutical manufacturing license field and a thorough understanding of the Drug Law 2016 regulations. We have successfully assisted hundreds of businesses in completing pharmaceutical manufacturing license procedures with a high success rate. Our consulting services are built on a profound understanding of stringent technical and legal requirements.

First: Advantage in Expertise and Experience

Our team includes pharmaceutical experts and lawyers with many years of experience in consulting for pharmaceutical manufacturing licenses. We are proficient in the regulations of Decree 54/2017/ND-CP and the latest guiding documents. Practical experience helps us identify potential issues early and provide suitable solutions for each specific case.

Long Phan Consulting Company continuously updates on changes in legal regulations concerning the production of drugs, pharmaceutical chemicals, and medicinal materials. We maintain positive relationships with regulatory agencies to ensure accurate and timely information. Our pharmaceutical manufacturing licensing service is designed based on a deep understanding of the practical implementation of legal regulations.

Second: Professional Working Process

Long Phan Consulting Company applies a standardized and professional working process in providing its pharmaceutical manufacturing licensing service. Each project is assigned to a team of experts with appropriate specialization and experience in handling similar cases. We use a modern project management system to track progress and ensure output quality.

A strict quality control process is applied to every stage of preparing the pharmaceutical manufacturing license dossier. Long Phan Consulting Company conducts multi-level checks to ensure the accuracy and completeness of the dossier before submission. Our consulting services comply with international quality management standards and are highly valued by clients.

Third: Commitment to Time and Efficiency

We commit to completing the pharmaceutical manufacturing licensing service in the shortest possible time while maintaining high quality. We optimize working processes and coordinate closely with competent authorities to shorten dossier processing times. Clients are regularly updated on implementation progress and any necessary coordination.

The pharmaceutical manufacturing licensing service at Long Phan Consulting Company offers high economic efficiency for businesses. We help clients save time and costs and avoid risks arising during procedural implementation. The professionalism and dedication of our consulting team ensure businesses can quickly commence pharmaceutical production operations.

Frequently Discussed Topics Regarding Pharmaceutical Manufacturing Licensing Service for Drugs, Pharmaceutical Chemicals, and Medicinal Materials

Below are some frequently discussed topics related to the article’s content:

The Nature and Importance of GMP Standards in Pharmaceutical Production?

GMP (Good Manufacturing Practices) are principles and regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards. GMP is crucial as it helps ensure the quality, safety, and efficacy of drugs, protecting consumer health.

Influence of Intended Product Type (Pharmaceutical Chemical, Medicinal Drug, Traditional Medicine) on the Licensing Process?

The product type affects specific GMP standards, requirements for facilities, equipment, testing processes, and personnel qualifications. Each product type may have distinct regulations within the guiding documents of the Drug Law.

Involvement of Other Agencies Besides the Ministry of Health in Appraisal and Licensing?

The article states the Minister of Health has authority for dossier reception and processing. However, during on-site facility appraisals, specialized units under the Ministry of Health (e.g., Drug Administration of Vietnam) or local Departments of Health may participate, depending on decentralization and facility type.

Enterprise Recourse if a License Application is Rejected?

If a dossier is rejected, the licensing authority provides a written response stating the reasons. The enterprise needs to carefully review the reasons for rejection, rectify shortcomings, or clarify information as requested, then resubmit the dossier.

Specific Activities Included in Long Phan Consulting Company’s Authorization Service?

The authorization service includes: representing in dossier submission, monitoring processing progress, handling amendment requests, coordinating and supporting on-site facility inspections, and receiving licensing results. This comprehensive support is central to our pharmaceutical manufacturing licensing service.

Ensuring Maintenance of Operating Conditions Post-Licensing?

After licensing, businesses must continuously maintain conditions related to facilities, technology, personnel, and quality management systems according to GMP standards. We provide periodic consulting on dossier updates, maintaining documentation systems, and handling arising issues.

Conclusion

The pharmaceutical manufacturing licensing service by Long Phan Consulting Company offers a comprehensive solution for businesses navigating complex legal procedures. With a team of experienced experts and a professional working process, we commit to assisting clients in completing all procedures quickly and effectively. For detailed consultation on the pharmaceutical manufacturing licensing service and sub-licenses, please contact our hotline: 1900.63.63.89.