Regulatory Aspects for the Reconditioning of Pharmaceuticals Products and Medical Devices in Peru

Q.F. Milagros Consuelo Arista Arévalo
Quality and Regulatory Affairs Specialist
SCR Consulting Peru

With the purpose of establishing the technical and sanitary conditions for the operation of Pharmaceutical Establishments, on July 2011, the “Regulation of Pharmaceutical Establishments” was published in the Official Newspaper El Peruano, approved through Supreme Decree No. 014-2011-SA. In this document, for the first time, the aspects related to the reconditioning of pharmaceutical products and medical devices are described in detail.

It is then that reconditioning is defined, according to D.S. No. 014-2011-SA and its subsequent amendments, as the set of operations to which a national or imported finished product is subjected, which may consist of:

• Placing the same product in a new packaging (primary or secondary).
• Inclusion or change of leaflet.
• Adding information on the packaging (primary or secondary) which print must be clear, legible and indelible in order to comply with the requirements of its sanitary registration.

According to Supreme Decree No. 029-2015-SA: Amendment of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products, in the case of medical devices, reconditioning refers to the addition of information on the primary or secondary packaging which printing must be clear, legible and indelible, a change of leaflet or instruction manual so that it can have the information required in its sanitary registration.

Before continuing this analysis on reconditioning, it is important to make a marked difference between the concept of reconditioning itself, previously mentioned, and the concepts of fractioning and conditioning.

Considering again the “D.S. No. 014-2011-SA and its amendments”, this document states that conditioning is defined as the operations to which a product that is already in its primary packaging has to be subjected, in order to become a finished product. While, on the other hand, this regulation mentions that fractioning is the division of the contents of a whole, whether it is a raw material, pharmaceutical product, medical device or health product that contains it, carried out in a laboratory authorized for such purpose. It should be made clear at this point that fractioning does not include reconditioning.

Drugstores may entrust pharmaceutical, medical device or health product laboratories with the reconditioning service, which must have Good Manufacturing Practices certification (GMP) or equivalent document issued by the competent Authority or Entity, as appropriate; according to Article 71° of Supreme Decree No. 016-2019-SA: Amendment of the Regulation of Pharmaceutical Establishments.

Likewise, as stated in the aforementioned Supreme Decree No. 016-2019-SA, drugstores that order the reconditioning service must request sanitary authorization from the National Authority of Pharmaceutical Products, Medical Devices and Health Products (ANM), in the scope of Metropolitan Lima, or from the corresponding Regional Health Authority (ARS), through the Authority of Pharmaceutical Products, Medical Devices and Health Products at Regional level (ARM).

According to the same regulations mentioned above, when ordering or extending the reconditioning service to national laboratories, the drugstore must request sanitary authorization, for which the following documents must be submitted to the DIGEMID:

1. a) Application in the form of a sworn statement, which can be downloaded from the DIGEMID website.
2. b) Copy of the contract between the parts related to the service to be provided, according to what is established in the Manual of GMP.
3. c) Copy of the GMP certificate of the national or foreign laboratory providing the manufacturing service granted by DIGEMID.
4. d) List of products to be reconditioned:
   – In the case of pharmaceutical products, the name of the product, the International Nonproprietary Name (INN), concentration and dosage form to be reconditioned must be included in the list.
   – In the case of medical devices, the name of the product or device and its classification must be included in the list.
   e) Additionally, the receipt of payment for the processing fee.

Likewise, laboratories may also entrust other laboratories, with prior authorization from the DIGEMID, the manufacture of products or devices, either in their entirety or in some steps of the manufacturing process such as reconditioning; presenting the documents mentioned above, as indicated in Article 109° of Supreme Decree No. 016-2019-SA.

According to this last Decree, it is precise that the responsibility for the quality of the product or medical device is assumed severally by the holder of the sanitary registration and the manufacturing laboratory, so we can evidence the importance of a collaborative and committed work between both sides. 

In June 2013, DIGEMID published the Notice “Reconditioning of pharmaceutical products, medical devices and health products”, being that through this document the regulatory entity authorizes the reconditioning service of products through Inkjet or Labels. With this notice, DIGEMID also states that, for the reconditioning of pharmaceutical products and medical devices, the following information may be added:

• Through Inkjet: Importer’s data, sanitary registration, name of the Technical Director (D.T.), name of the reconditioning laboratory.
• Through label (Sticker): Importer’s data, name of the D.T.

Likewise, the previously mentioned Notice indicates the data or information that are not authorized as reconditioning services, which are as follows:

• Name of the Product
• Name and Country of the Manufacturer Laboratory
• Batch Number
• Expiration Date
• International Nonproprietary Name 
• Concentration.

However, in the case of imported medical devices whose labeling does not include, originally, the name of the manufacturer in accordance with the Directorial Resolution of inscription or re-inscription, the DIGEMID indicates that it will allow the reconditioning to include the name of the manufacturer (legal or actual, as appropriate).

On the other hand, for the year 2017, according to Supreme Decree No. 016-2017-SA: Amendment of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products, it is provided that the name of the laboratory performing the reconditioning will no longer be required, as well as the inclusion of the name of the Technical Director in the labeling of the secondary and primary packaging of pharmaceutical products and medical devices may be exempted.

In that way, for the reconditioning of pharmaceutical products and medical devices, the following information may be added:

In practice, as part of the quality assurance system, the national laboratories that perform the reconditioning of pharmaceutical products or medical devices normally request the following documents from the drugstores or laboratories requesting the service:

• The order for the reconditioning service.
• List of products to be reconditioned.
• Sanitary Registration of the products to be reconditioned.
• Certificate of Analysis or Certificate of Conformity of the products to be reconditioned.

In the meantime, the requesting drugstores or laboratories ask their reconditioning service providers for the Finished product inspection reports.

Currently for the order or extension of the reconditioning service, laboratories and drugstores make a Communication of Order of Reconditioning Service to the DIGEMID, for which they submit the same requirements detailed in the D.S. No. 016-2019-SA, using the Orientation Format as a request with character of sworn statement which is downloaded from the DIGEMID web page and excepting the payment voucher, since this procedure has no cost. In that way, as it is a communication, DIGEMID does not issue a Directorial Resolution of Authorization. In support of the authorization and as evidence in audits, the drugstores or laboratories file the documentation submitted to the Authority and print the DIGEMID’s Documentary Processing System’s “File Inquiry” in status of ATTENDED.

It should be noted that drugstores or laboratories may have one or more suppliers that provide them with the product reconditioning service, for which they must make the respective Communication to DIGEMID for each supplier separately, complying with the requirements mentioned above for each one.

It is important to remember that drugstores and laboratories that infringe in manufacturing, importing, storing, distributing, commercializing or dispensing medical products or medical devices, without consigning or modifying in the labeling of the secondary or primary packaging technical information approved in the sanitary registration or other information required in the sanitary labeling norms, or consigning unauthorized technical information, with the exception of the lot number, expiration date, and of those products or medical devices to which information was authorized according to the sanitary registration or in stock depletion, will have a sanction amounting to 3UIT (Unidad Impositiva Tributaria, which is defined as the value in ‘soles’ (Peruvian currency) established by the State to determine taxes, infractions, fines and other tax matters), this according to the provisions of Supreme Decree No. 029-2015-SA. 

From the above-mentioned evaluation, it can be observed that, in recent years, in Peru, the guidelines and processes for the reconditioning of pharmaceutical products and medical devices have been increasingly better detailed, through national technical standards, which allows those responsible for quality assurance of drugstores and laboratories to implement a more robust quality management system and ensure the quality of the products delivered to the population.