DIGEMID’S Approval Process: A Guide for Manufacturers and Exporters

Introductory

DIGEMID, the General Directorate of Medicines, Supplies, and Drugs in Peru, is a vital regulatory authority established on April 18, 1990, under the Ministry of Health. Its primary mission is to ensure that the Peruvian population has access to safe, effective, and high-quality medicines and health products. This agency plays a crucial role in regulating pharmaceuticals, medical devices, and dietary supplements to promote public health.

Functions of DIGEMID

Approved Manufacturers and Suppliers

Pharmaceutical manufacturers and suppliers are required to undergo a thorough certification process by DIGEMID to comply with Good Manufacturing Practices (GMP). Obtaining certification from DIGEMID ensures that these manufacturers and suppliers meet international quality standards, guaranteeing the production of safe, effective, and reliable pharmaceutical products. This certification highlights their commitment to consumer safety and quality, and it is essential for obtaining drug registration approval and expanding export opportunities.

Being A DIGEMID Approved Site Registration and Licensing Requirements

Site Registration for DIGEMID Certification

To manufacture a pharmaceutical product in Peru, the site must be approved by DIGEMID and obtain Sanitary Registration. This registration allows the manufacturer or supplier to produce, import, store, distribute, market, and sell the product in compliance with local regulations. The plant can be a local manufacturer or a foreign exporter outsourcing production, but all must adhere to certified practices, such as Good Manufacturing Practices (GMP). Foreign suppliers with certified GMP from high surveillance countries or those with mutual recognition agreements with Peru are also accepted. Local manufacturers must secure the Sanitary Authorization from DIGEMID and an operating license from local authorities.

How to obtain a Plant GMP certificate from DIGEMID?

In order to obtain the Sanitary Authorization as a laboratory they must comply with the following requirements:

• Production areas, storage and pharmaceuticals forms to fabricate
• Technical Director
• Sketch of the location of the establishment
• Sketch of the distribution areas of the laboratory. In the storage area the useful volume of storage must be indicated en cubic meters for each area
• Flow diagram of the production processes, by pharmaceutical form, indicating the quality controls for each stage of the process
• Zoning license
• Sketch of critical support systems
• List of critical equipment for production and quality control

After obtaining the Sanitary Authorization, they must obtain the certificates of Good Practices issued by the DIGEMID.

In case the manufacturing laboratory carries out the quality controls (tests) on the inputs, the intermediate products or devices and the finished product or device, it can do so in accordance with what the Good Laboratory Practices establish.

Product registration process for DIGEMID Approved manufacturer

• Appoint an Authorized Representative

Foreign manufacturers must appoint an Authorized Representative or a Peru Registration Holder (PRH) to handle the registration with DIGEMID. local representative to handle regulatory processes and communication in Peru

• Determine classification

Identify the classification of the product Category based on Active pharmaceutical ingredients

• Preparation of technical documentation

Compile Documentation: Gather necessary documentation, clinical data, and product information

• Submit application

Submit the application along with the dossier to the DIGEMID.

• Technical review & product testing

DIGEMID conducts a technical review of the submitted documentation to ensure it meets regulation

• Audit and Inspection

The manufacturing site may be subject to audit and inspection by DIGEMID

• Approval and registration:

The certificates of Good Manufacturing Practices issued by the DIGEMID. Product is approved and registered in Peru.

Pharmaceutical products Registration requirements in Peru

As for pharmaceutical products drugs, 3 categories are established

^**Clinical and pre-clinical studies as applicable.

With the approval of the “Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products”, through Supreme Decree No. 016-2011-SA, new regulations, foundations and technical criteria are established for the evaluation of medicines based on evidence of efficacy, quality and safety.

The general requirements for the inscription of pharmaceutical products are established in the following table presents the list of requirements for each category of pharmaceutical product:

^*This requirement will be applied after four years from the effective date of the corresponding regulations.

^**Currently, we have a list of medicines for the requirement of the presentation of therapeutic equivalence studies to demonstrate the interchangeability regulated by Supreme Decree No. 024-2018-SA “Regulations governing the interchangeability of medicines”. Published: September 15, 2018. This means that not all pharmaceutical products are required to submit these studies.

^***The Certificate of Free Sale will only be accepted if the Regulatory Agency of the country where the pharmaceutical product was manufactured does not issue a Certificate of Pharmaceutical Product.

^**** The efficacy and safety of the pharmaceutical product will be supported through studies, if it presents a different pharmaceutical form, quantity of Active Pharmaceutical Ingredient-API or route of administration to that of the National Unique List of Essential Medicines or to that authorized in a High Sanitary Surveillance Country, for category 1 and 2 pharmaceutical products, respectively.

Timeline for DIGEMID Approval

Associated Fees for DIGEMID Approval

• • Product registration fees: $400 to $1,200
  • Sanitary Authorization for registration as a laboratory the fees: $250
  • Sanitary Authorization for registration as a drugstore the fees: $150

Validity Of Certificate for DIGEMID Approved Manufacturer in India

Sanitary Registrations are valid for 5 years and they can be renewed starting one year before their expiration date. For the renewal the owner of the registration must present all the requirements for registration except for studies supporting the efficacy and safety of the product.

Challenges for Manufacturer for getting DIGEMID Approval

• Complying with strict regulatory guidelines
• Reporting clinical trial results
• Controlling registration-related expenses
• Maintaining high-quality standards adherence
• Staying up-to-date with regulatory shifts and policy modifications
• Delivering all necessary documentation
• Overseeing project timelines and mitigating delays
• Managing language and cultural barriers
• Setting up local partnerships and representation
• Carrying out ongoing post-market monitoring

Conclusion

For a certified and approved manufacturer, securing DIGEMID registration for pharmaceutical products in Peru is crucial for market access. The process involves meeting strict regulatory requirements, ensuring the manufacturing plant complies with GMP, and providing necessary documentation. Both local suppliers and foreign exporters must appoint a representative, manage costs, and navigate potential challenges. Once approved, the site’s registration is valid for five years, guaranteeing the product’s safety and quality for the Peruvian market.