The ins and outs of biosimilars & biologics in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, they are different. On one side biosimilar products are biologically synthesized products which require a much more complex procedure to elaborate due to the fact that bigger molecules are being synthesized (such as growth hormones) while generics have more simple chemical structures and are considered identical to an already existing product.  

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

There is no prohibition for the patentability of biosimilar medicines provided they comply with inventive requirements.  

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

Yes, there is a specific regulatory framework for the marketing authorization of biosimilar medicines in Peru, Supreme Decree N° 013-2016-SA, Regulation for the Filing and Content of the Required Documents in the Registration of Biologic Products that Opt for the Similar Way.  

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

Yes, the approval of biosimilar drugs requires the filing of additional documents such as the comparison with the Biological Product of Reference.  

5. What are the requirements for the choice of the reference comparator product?

The following requirements must be considered:

1. Registration in Peru or a country of high sanitary surveillance
2. It cannot be a biosimilar
3. The same BPR must be used during the entire process
4. The Pharmaceutical Active Ingredient of the Biosimilar and the BPR must show the similarity.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, provided it has been registered for commercialization in a country of high sanitary surveillance.  

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

The prices of biosimilars are not regulated.  

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

Reimbursement policies are determined by the company selling the product and are not regulated.  

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Reimbursement policies are determined by the company selling the product and are not regulated.  

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

There is no special framework for the prescription or dispensing of biosimilars. Consequently, general health laws apply.  

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

Yes, it considers physician-led switching and/or pharmacy-level substitution.  

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

The post authorization requirements are not different from Biologic drugs and, being that in both cases, the fabricants and importers must report any suspicions of adverse reactions or events.  

13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?

Second Use Patents are not allowed in Peru.  

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

There have been no recent developments.  

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

There is no proposal to reform or significantly change the procurement of biosimilars.  

Also from this Legal Handbook

Key legal info on orphan drugs & rare diseases in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. What is the definition of Rare Diseases in your country?

Rare Diseases are defined, by Supreme Decree No. 004-2019-SA, as those with danger of death or chronic disability, which have a frequency of less than 1 disease per 100,000 people. In some cases, they are difficult to detect and, in most cases, have an unknown origin which carry social problems and have little epidemiological data. They may include congenital malformations and diseases of genetic origin.  

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

The designation does exist, and is defined as those that have demonstrated a favourable risk-benefit ratio in the prevention, diagnosis and/or treatment of rare and/or orphan diseases that have low or no pharmaceutical production, which results in limitations in their supply in the market.  

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The Ministry of Health, through a Ministerial Resolution, authorizes the use of medicines for rare or orphan diseases including them in the Single National Petition for Essential Medicines. Medicines for rare and/or orphan diseases are subject to evaluation of sanitary technology, budget impact analysis and budged availability and intense pharmacovigilance. Furthermore, pharmaco-therapeutic following of the patients is realized in order to determine problems with the medicines.  

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

There are no special provisions for clinical trials in respect with Orphan Drugs.  

5. Is there an expedited pathway for Orphan Drugs?

There is not an expedited pathway for Orphan Drugs.  

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Foreign marketing authorizations are not recognized for Orphan Drugs.  

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

There is not a process for the reimbursement of Orphan Drugs.  

8. How are the prices of Orphan Drugs regulated?

The prices of Orphan Drugs are not regulated; however, they are partially funded by the State.  

9. In case of reference price based on a basket of countries, what countries are included?

N/A.  

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No developments have been made regarding Orphan Drugs.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

There are no proposals for reform.  

Also from this Legal Handbook

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Greece. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.  

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

In our country, Cannabinoid Drugs are only allowed in the form of Medical Cannabis, for informed use, research, production, import and trade for medicinal and therapeutic purposes, as it is regulated by Law N°30681 and its Regulation. The possession, promotion, financing, export, import, production of Cannabinoid Drugs for other purposes is qualified as a crime, as indicated in our Criminal Regulation.  

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The regulatory authorities with jurisdiction over Cannabinoid Drugs for medical and therapeutic purposes are the Ministry of Health through the General Direction of Medicines, Supplies, and Drugs (DIGEMID), and the National Health Institution (INS), and the Ministry of Agriculture and Irrigation through the National Service of Agricultural Sanity (SENASA) and the National Institute of Agriculture Innovation (INIA).  

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

Law N° 360681 and its Regulation are the regulatory framework regarding Cannabinoid Drugs (Medical Cannabis). There is no regulation regarding its pricing and reimbursement.  

4. Which are the cannabinoid drugs that have received market approval to date?

Only Medical Cannabis and its derivatives have received market approval.  

5. Who can prescribe Cannabinoid Drugs?

Local Regulation indicates that only Medical Surgeons can prescribe Cannabinoid Drugs, and only, for medicinal and therapeutic purposes.  

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There is not an authorized list of doctors allowed to prescribe Cannabinoid Drugs.  

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Regarding production, a license, allowing for the acquisition of seeds and/or seedlings of Cannabis, planting, propagation, cultivation, harvest, post-harvest, and manufacture of Cannabis-derived products, as well as storage and transportation activities of seeds, seedlings, plants, flowers, and products derived from Cannabis for medicinal use, is required. In that regard, there are 3 types of licenses, one including farming, one not including farming and one including the production of seeds. Regarding import, a commercialization and import license, previous compliance of the requirements established in the regulations of Law N° 30681, are required.  

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Any pharmaceutical establishment that has been granted a commercialization license, previous compliance of the requirements established in the regulations of Law N° 30681, are authorized to sell or distribute Cannabinoid Drugs for medical or therapeutic purposes, previous fulfilment of the conditions established in the Regulation of Pharmaceutical Establishments.  

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

There is a National Registry of Natural and Pharmaceutical Establishments, managed by DIGEMID, that are allowed to commercialize and/or import Cannabinoid Drugs and its derivatives.  

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

In 2020, Bill 06532-2020-CR which aims to regulate the cultivation and processing of cannabis and its derivatives by patients and patient associations for exclusive medicinal and therapeutic use was filed. This bill proposes that associations and natural persons that have a license to cultivate cannabis are exempted from criminal responsibility, as long as it is only for the exclusive use of a medical or therapeutic nature. For such purposes. Furthermore, it aims to modificate Law N° 360681 in order to permit self and associative cultivation.  

11. When are they likely to come into force?

N/A.  

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medical Cannabis is authorized for medicinal and therapeutic purposes, as it is indicated by Law N°30681 and its Regulation.  

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The Ministry of Heath through the General Direction of Medicines, Supplies, and Drugs (DIGEMID), and the National Health Institution (INS), and the Ministry of Agriculture and Irrigation through the National Service of Agricultural Sanity (SENASA) and the National Institute of Agriculture Innovation (INIA).  

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Law N° 360681 and its Regulation are the regulatory framework regarding Medical Cannabis. There is no regulation regarding its pricing and reimbursement.  

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

The production and import of Medicinal Cannabis is regulated by Law N°30681 and its Regulation. The competent authority for the production is the Ministry of Health, through the General Direction of Medicines, Supplies, and Drugs (DIGEMID) and the National Health Institution (INS); and for the import is the Ministry of Agriculture and Irrigation through the National Service of Agricultural Sanity (SENASA) and the National Institute of Agriculture Innovation (INIA).  

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Regarding production, a license, allowing for the acquisition of seeds and/or seedlings of Cannabis, planting, propagation, cultivation, harvest, post-harvest, and manufacture of Cannabis-derived products, as well as storage and transportation activities of seeds, seedlings, plants, flowers, and products derived from Cannabis for medicinal use, is required. In the regard, there are 3 type of licenses, one including farming, one not including farming and one including the production of seeds. Regarding import, a commercialization and import license, previous compliance of the requirements established in the regulations of Law N° 30681, is required.  

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

The regulatory framework of Medical Cannabis is regulated in Law N° 360681 and its Regulation.  

18. How can patients obtain Medicinal Cannabis?

In order to acquire Medicinal Cannabis, any patient must be registered in the National Registry of Cannabis Patients. In order to be registered, the patient or his doctor must register the patient through a virtual affidavit in DIGEMID’s web page.  

19. Who can prescribe Medicinal Cannabis?

Only Medical Surgeons can prescribe Medicinal Cannabis as it is indicated by article 21 of the Regulation of Law N°30681.  

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

There is no list of doctors authorized for prescribing Medicinal Cannabis.  

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Only a Medical Surgeon can prescribe Medical Cannabis. Furthermore, a special recipe must be used in which identification information regarding both the patient and the doctor as well as information regarding the prescribed Cannabis according to the Regulation of Law N° 30681, must be consigned clearly and precisely, without leaving any blank space or amendments. The receipt is valid for thirty (30) days.  

22. Where is Medicinal Cannabis available?

   

Also from this Legal Handbook

Regulatory reforms in Peru - an overview. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. Are there proposals for reform or significant change to the healthcare system?

There are no proposals that imply a significant change to the healthcare system.  

2. When are they likely to come into force?

N/A.  

Also from this Legal Handbook

An outline of the situation regarding patents and trademarks in Peruvian pharma. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. What are the basic requirements to obtain patent and trademark protection?

A patent application must comply with 3 basic requirements, meaning that a patent must have:

• Novelty
• Inventive Level
• Industrial Application

A trademark application must both be distinctive and must be able to differentiate itself from other registered trademarks.  

2. What agencies or bodies regulate patents and trademarks?

Patents and trademarks are regulated by the National Institute for the Defence of Competition and Intellectual Property (INDECOPI in Spanish)  

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Any product can be protected with a trademark. Any product, process and substance that complies with the requirements established in question 2 can be protected. However, the following will not be considered inventions:

• Discoveries, scientific theories and mathematical methods;
• All or part of living beings as they are found in nature, natural biological processes, the biological material existing in nature or one that can be isolated, including genome or germplasm of any to be a natural alive;
• Literary and artistic works or any other protected by the right of Author;
• The plans, rules and methods for the exercise of intellectual activities, games or economic-commercial activities;
• Computer programs or software, as such;
• The ways by which information is presented

 

4. How can patents and trademarks be revoked?

Trademarks can be revoked with a nullity action if the trademark was granted contrary to regulation. Furthermore, they can be cancelled if they haven’t been used after the grace period (3 years) expires. Patents can only be revoked with a nullity action if it was granted contrary to regulation.  

5. Are foreign patents and trademarks recognized and under what circumstances?

Foreign trademarks are recognized in the following circumstances:

• Any trademark registered in Ecuador, Colombia and Bolivia will have the same protection as a trademark registered in Peru provided the owner of these trademarks proves to have a real interest in the market. (i.e., An opposition can be filed with a Colombian registration but an application for an identical trademark must be filed)
• A trademark might receive protection from the Washington Convention regarding the possibility to oppose a similar application in Peru. In order to do so the oppose must comply with these requirements:
  • Ownership of a registration in a country from the Washington Convention
  • Evidence that the applicant has a previous knowledge of the existence of the registered trademark.
  • Evidence of the first and current use of its trademark.
  • Domicile in a country from the Washington Convention

Foreign patents are recognized under the PCT and Paris agreement granting a total of 30 months for a patent application.  

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

There are no other barriers to protect medicines or devices. However, commercialization, import, distribution and/or storage require an authorization.  

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

There is no restriction in the types of medicines or devices than can be granted patent and trademark protection.  

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

A license agreement must not be approved or accepted by any government or regulatory body but it must be registered for it to be opposable to third parties.  

Also from this Legal Handbook

Get to know the legal situation around product liability in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. What types of liability are recognized in your jurisdiction?

Regarding the quality of the pharmaceutical products and medical devices the responsibility will lie with the manufacturing company when these are made in the country, with the importer holding the Sanitary Registration when manufactured abroad. In the case of establishments in charge of preparing, storage or distributing products on behalf of third parties the responsibility is assumed both by the company owner and the holder of the Sanitary Registration.  

Furthermore, the technical director is responsible for the compliance of quality requirements of the pharmaceutical products and medical devices, having joint liability with the legal representative of the establishment.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

As stated in the previous question, they lie with the manufacturing company when made in the country, with the importer holding the Sanitary Registration when manufacturing abroad. The responsibility is joint and shared with the technical director and the legal representative of the establishment.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Liability extends to the technical director and legal representative.  

4. How can a liability claim be brought?

A liability claim can be brought by the sanitary authority ex officio following the quality control to which every batch of products is subject or the seizing of a product in a regular inspection or bonded warehouses.

Furthermore, an affected third party may alert the sanitary authority of a potential infraction. However, the part alerting the authority is not a part of the process. 

 

5. What defenses are available?

The available defences will change depending on the procedure; however the main defence mechanisms available are the immediate correction of the infringing conduct and to credit that the procedure consigned in the enabling title has been followed.

 

Also from this Legal Handbook

The ins and outs of the legal requirements for traditional medicines and OTC medicines in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Storage, Commercialization, importation, distribution require, with the exception of alternative medicine, a Sanitary Registration for each product.  

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

They can be advertised as long as they do not require a prescription provided they comply with local regulation which implies including the doses and main warning of precautions consigned in the Sanitary Authorization.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Health, advertising and marketing claims must match the Sanitary Authorization for the product. Furthermore, the dosage, and main warnings and precautions of the products must always be mentioned. In the case of herbal products, the general information of the medicinal herpes included in the composition must be included.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over the counter medications require a Sanitary Authorization for their Storage, Commercialization, importation and/or distribution.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

There is no limitation to the locations through which OTC products can be sold.

 

6. What health, advertising, and marketing claims may be made for OTC products?

Health, advertising and marketing claims must match the Sanitary Registration for the product. Furthermore, the doses, and main warnings and precautions of the products must always be mentioned.  

7. Can OTC products be marketed or advertised directly to the public?

Over the counter products can be commercialized and advertised directly to the public  

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

A prescription medicine can be converted to an Over-the-Counter product provided that, in addition to meeting the criteria for being sold without a prescription it fulfils the following requirements:

• Show a favourable safety and efficacy index with drug monitoring data.
• Not shown an increase in adverse results in the period of commercialization.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Importation of medicines must comply with the following requirements:

• Resolution that authorizes the Sanitary Registration or the Certificate of Sanitary Registration.
• Shipment Identification per fabrication batch.
• For products derived from human plasma, a Certificate certifying HIV and Hepatitis B, C negativity.
• For biological products derived from bovine, sheep and goat, a Certificate certifying bovine spongiform encephalopathy negativity.

 

Also from this Legal Handbook

The key info on marketing, manufacturing, packaging & labelling and advertising pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

Any new drug, biologic, medical device, over the counter medication and in general medicinal product require a Sanitary Registration. In order to obtain a Sanitary Registration, the applicant must be properly registered as a laboratory or Drugstore which implies complying with certain requirements including having a Certificate of Good Practice and employing a Chemist. Furthermore, when requesting a Sanitary Registration, the technical and chemical information of the product must be presented as well as the proposed label of the product.  

2. What is the authorization process for the marketing of generic versions of these products?

There is no difference in regulation for the marketing of generics.  

3. What are the typical fees for marketing approval?

Typical fees for marketing approval will depend on the product whose Sanitary Registration is being requested and range from $400 to $1,200.  

4. What is the period of authorization and the renewal process?

The authorization is valid for 5 years and they can be renewed starting one year before their expiration date.  

5. What are the requirements, if any, for post-approval pharmacovigilance?

Security reports must be sent as follows:

• Every 6 months for the first 2 years after the authorization date.
• Annually for the next 3 years.
• Every 5 years starting on year 6.

 

6. Are foreign marketing authorizations recognized?

There is no foreign marketing authorization that can enable you to commercialize products without a Sanitary Registration obtained in Peru. 

However, within the requirements needed for a Sanitary Registration of foreign documents such as the Certificate for Free Sale or a Certificate of Good Manufacturing Practices from countries with high sanitary vigilance can be recognized.

 

7. Are parallel imports of medicines or devices allowed?

Lack of regulation allows for parallel imports provided the importer has the Sanitary Authorization for commercialization of the product.  

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Regarding such marketing practices, Peruvian regulation forbids any activity that promotes the commercialization, prescription or distribution of pharmaceutical products in the pharmaceutical establishments Furthermore, in medical establishments medical visitors or other agents of a pharmaceutical company must not have access to medical offices nor interfere with the activities that health professionals carry out with their patients. Likewise, the sanitary regulation establishes that health professionals may only appear in advertising through the publicity of their testimonies if they are backed by recent, authentic and verifiable experiences. Finally, the ethical criteria, established by the Pan-american and World Health Organization which state that no incentive must be given to any professional in charge of the prescription or distribution of pharmaceutical products.  

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The manufacture of pharmaceutical products and medical devices are regulated by the provisions of Law N° 29459, Law on pharmaceutical products, medical devices and sanitary products and its regulations approved by Supreme Decrees No. 014-2011-SA and No. 016-2011-SA, and complementary rules. For manufacturing, the Sanitary Registration of the product or device is required. Manufacturing can be done directly, if the owner is a duly authorized laboratory at the local level or the manufacturing can be ordered to another national or foreign laboratory, which must comply with the regulatory conditions, whose point has been developed in Question 3 of Regulatory, Pricing and Reimbursement. The authority in charge of granting the Sanitary Registration of the product or device, the Sanitary Authorization of operation of the laboratory as well as the certificates of good practices is DIGEMID by order of the Ministry of Health.  

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Local manufacturing requirements are compatible with the GMPs as defined by the FDA according to the List of Documents considered equivalent to the Certificate of Good Practices.  

11. What is the inspection regime for manufacturing facilities?

There are 2 types of inspection. First, to obtain the Sanitary Authorization to function as a manufacturing facility a previous inspection by DIGEMID is required, in which compliance with the Good Manufacturing, Laboratories and Storage Practices is verified. A resolution, granting or rejecting authorization is issued in the next 30 days after the procedure starts. When the manufacturing facilities are working, inspections are conducted by Chemists under the directions of DIGEMID. In order to enter the pharmaceutical establishment, they must have, in addition to their ID, a presentation letter subscribed by the incumbent of DIGEMID. During the inspection, the inspectors can request the documentation regarding the fabrication procedures. They are also able to perform all kinds of controls, seizure of products, verification. The seizure of products can be done with the purpose of verification that the conditions over which authorization was granted is fulfilled. The seizure of products may occur at any stage of the fabrication process. Whoever is present at the establishment must allow the inspection to be conducted properly.  

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Manufacturing facilities are open for foreign inspector provided a cooperation agreement has been reached with a foreign regulatory body.  

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Regarding packaging it must be innocuous and adequately guarantee that the product or device will maintain the composition, quality and quantity declared by the manufacturer. Regarding storage the establishments must comply with the regulation for Good Storage Practices. Regarding the handling of medicines and devices they must be conducted in a laboratory with the appropriate authorizations.  

14. What information must be included in medicine and device labelling?

The labels of pharmaceutical products and medical devices must include the following:

• Pharmaceutical specialty and Ingredients
• Pharmaceutical Form and content (volume or doses)
• List of excipients whereof there is a recognized effect
• Route of administration
• Warning and Precautions
• Warning to maintain away from children
• Expiration date
• Storage Conditions
• Commercialization Conditions
• Technical Director name
• Name and Country of the Lab that manufactures the product or device
• Contact information of the holder of the Sanitary Registration
• Contact information of the importer.
• Sanitary Registration Number (RS N°…)
• Badge Number

 

15. What additional information may be included in labelling and packaging?

Only information approved in the Sanitary Registration may be included.  

16. What items may not be included in labelling and packaging?

Affirmations guaranteeing that the product might cure you from a disease cannot be advertised in the label or packaging, nor can information that may induce auto medication in the consumers. Furthermore, tags cannot be attached to the packaging to correct or add information except those that would indicate information regarding the importer, Technical Director or any information authorized by DIGEMID Finally, information not consigned in the Sanitary Registration may not be consigned.  

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

The advertising for pharmaceutical products and devices must include the main warnings and precautions authorized in the Sanitary Registration and the adequate doses. Furthermore, exaggerations or inaccuracies that might mislead the consumer cannot be included.  

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Pharmaceutical products and devices may be sold in any establishment that has been granted a Sanitary Authorization. The only exception for this authorization is the commercialization of products with very low sanitary risk.  

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

Advertising by electronic means must include the main warnings and precautions authorized in the Sanitary Registration and the adequate doses. Furthermore, exaggerations or inaccuracies that might mislead the consumer cannot be included. Finally, it is worth mentioning that the main warnings and precautions must be presented in a clear way that is proportional to the duration of the advertising. (i.e. in a radio advertising they cannot be spoken faster than the rest of ad) Regarding commercialization, it is authorized for products and medical devices both with and without a prescription with the exception of narcotics, psychotropic and other that are subjected to sanitary control. It must take place in vehicles or containers that are properly conditioned to comply with the regulation of Good Storage, Distribution and Transport Practices. Good Distribution Practices must also be ensured.  

20. May medicines and devices be advertised or sold directly to consumers?

Medicines and devices may be advertised and sold directly to consumers as long as they do not require a medical prescription.  

21. How is compliance monitored?

Every batch of products entering the market is subject to a quality control. Furthermore, local health authorities may inspect establishment that store, distribute, commercialize pharmaceutical products and confiscate the products for analysis in any step of the fabrication, storage, distribution or commercialization process.  

22. What are the potential penalties for noncompliance?

Confiscations can also be made at bonded warehouses for imported products. Penalties for noncompliance go as follow:

• Small fines
• Suspension of the Technical Director
• Bigger fines
• Cancelation of the Certificate for Good Practices
• Suspension of the Sanitary Registration
• Cancelation of the Sanitary Registration
• Temporary suspension of the fabrication or commercialization activities
• Temporal closure of part or all facilities
• Definitive closure of the establishment or its facilities.
• Confiscation of products, devices, materials and/or machinery

 

Also from this Legal Handbook

Want to know about preclinical and clinical trial requirements in Peru? Read on! Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

Peruvian law only regulates clinical trials conducted locally.  

2. How are clinical trials funded?

Clinical trials are funded by a sponsor.  

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

The preclinical and clinical trial protocols must file the following documents for authorization:

• Application for the authorization of the clinical trial
• Copy of the registration of the authorized research centres.
• Copy of the document approving the investigation protocol and the format for the informed consent.
• Affidavit by the sponsor signalling the compliance of the responsibilities in the local regulation.
• Affidavit by lead investigator signalling the compliance of the responsibilities in the local regulation.
• Affidavit by the lead investigator and the sponsor signalling that there are no financial conflicts of interest.
• Affidavit by the lead investigator and the sponsor regarding the conditions of the research centre.
• Copy of the insurance policy.
• Affidavit of the sponsor signalling that he counts with a financial fund that can guarantee immediate attention and free treatment if any subject were to suffer an adverse effect.
• Clinical protocol in Spanish and original language (if other)
• Updated Investigator’s brochure
• Information regarding the quality of the product being investigated
• Copy of the document that certifies the capacitation in Good Clinical and Ethical Practices in Investigation in human beings of the entire investigation team which must be at most 3 years old.
• Total national budget of the clinical trial.
• List of the supplies needed for the development of the clinical trial.

 

4. What are the requirements for consent by participants in clinical trials?

The Executive Office of Technology Transfer and Training (OGITT in Spanish), which is attached to National Health Institute must approve the clinical trial after the evaluation of the protocol by DIGEMID which is binding. Prior to obtaining consent, the research subject must be provided clear information regarding the clinical trial both verbally and written. Verification that the research subject understood is needed. Furthermore, enough time must be given to the subject before a decision is made and all his questions must be solved. Informed consent is required previously to even verify eligibility criteria and it must be submitted in the appropriated format. Informed consent requires Approval by a Research Centre of the Institution where the clinical trial will be conducted and must be redacted both in Spanish and the research subject’s native language. Finally, it must include the following information:

• The object, justification and purpose of the trial.
• Treatments of the clinical trial.
• Procedures to be used and their purpose.
• Number of research subjects both locally and worldwide
• Expected time of participation
• Inconveniences and expected and unforeseen risks.
• Expected benefits.
• The existence of alternative procedures that could be advantageous to the research subject.
• Contact information of the lead investigator and the President of the Research Centre as corresponds (as a guarantee to receive an answer to questions or doubts regarding the clinical trial, risks, benefits)
• Insurance that the research subject will not be identified and that information regarding privacy will remain private.
• That the research subject is granting the Research Centre access to his clinical history
• Reasons why the trial or the subject participation may end.
• Availability of the medical treatment and the compensation to which the subject would have a legal right for damages by the investigation, indicating the insurance hired by the sponsor.
• Detail of economic compensation for additional expenses such as transport, housing, communication and food if applicable.
• Potential risk in pregnancy if applicable.
• Information regarding how and when the research subject will receive information regarding the clinical trial results.

 

5. May participants in clinical trials be compensated?

They can receive a reasonable compensation for extraordinary expenses and the lack of productivity arising from their participation. Compensation will be monitored per case to ensure that it does not improperly influences the participants consent.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The principal investigator and the sponsor are responsible for providing attention and free medical treatment to any participant that suffers any damage as a result from the trials. Furthermore, the sponsor is responsible to provide compensation to the participant for damages during the trial.

 

Also from this Legal Handbook

An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.  

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

Drugs, biological and medical devices are regulated by the Directorate General of Medicines, Supplies and Drugs - (known in Spanish as DIGEMID)  

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The regulatory frameworks for authorization, pricing and reimbursement of drugs, biological and medical devices are the following:

• Law N° 29459, Law on pharmaceutical products, medical devices and sanitary products
• Supreme Decree N°014-2011-SA
• Supreme Decree N° 016-2011-SA

 

3. What are the steps to obtaining authorization to develop, test, and market a product?

For the manufacture of a pharmaceutical product, it is necessary to obtain its Sanitary Registration. It should be noted that obtaining the sanitary registration of a product authorizes its owner for the manufacture, import, storage, distribution, marketing, promotion, dispensation, sale or use thereof, under the conditions established by local regulations.

In that regard, there are two figures that can be presented. On one hand if the owner is a local laboratory, able to directly manufacture the products to later commercialize them or it can order the manufacturing service to a national or foreign laboratory. Regardless, the laboratories must comply with the requirements and sanitary conditions established in local law and have the Certificates of Good Manufacturing Practices, Good Laboratory Practices, Good Distribution Practices, Good Storage Practices, Good Dispensing Practices and Good Practices of Pharmacotherapeutic Follow-up and others approved by DIGEMID. Regarding foreign laboratories, certificates of Good Manufacturing Practices are recognized in high surveillance countries or countries of mutual recognition with Peru.

Considering the aforementioned, the manufacture of a pharmaceutical product, must be carried out by an authorized national laboratory, which must maintain all the conditions by which manufacture of the product was authorized.

In that regard, for the fabrication of pharmaceutical products local laboratories must have certificates of Good Practices, the Sanitary Authorization issued by DIGEMID and the Operating License issued by the local government.

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

• a) Production areas, storage and pharmaceuticals forms to fabricate;
• b) Technical Director;
• c) Sketch of the location of the establishment;
• d) 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;
• e) Flow diagram of the production processes, by pharmaceutical form, indicating the quality controls for each stage of the process;
• f) Zoning license;
• g) Sketch of critical support systems;
• h) 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.  

4. What are the approximate fees for each authorization?

Regarding the commercialization authorization, the fees will depend on the product whose Sanitary Registration is being requested and range from $400 to $1,200. Regarding the Sanitary Authorization for registration as a laboratory the fee is of around $250 Regarding the Sanitary Authorization for registration as a drugstore the fee is of around $150  

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

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.  

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The authorization process is the same for both type of products. No distinction is made between a local manufacturer and a foreign manufacturer.  

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

Products may be commercialized in kits prior to communication to DIGEMID as long as they maintain the conditions by which their Sanitary Registration was granted.  

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Every batch of products entering the market is subject to a quality control. Furthermore, local health authorities may inspect establishment that store, distribute, commercialize pharmaceutical products and confiscate the products for analysis in any step of the fabrication, storage, distribution or commercialization process.

Confiscations can also be made at bonded warehouses for imported products.

The regulation regime is very strict and as such it could be said that it is comparable to the European and American standards.

 

9. What is the potential range of penalties for noncompliance?

The range of penalties for noncompliance goes as follows:

• Warning against the owner or legal representative or technical director
• Suspension of the Technical Director
• Fines
• Cancellation of the Certificate for Good Practices
• Suspension of the Sanitary Registration
• Cancellation of the Sanitary Registration
• Temporary suspension of the fabrication or commercialization activities
• Temporal closure of part or all facilities
• Definitive closure of the establishment or its facilities.
• Confiscation of products, devices, materials and/or machinery

 

10. Is there a national healthcare system? If so, how is it administered and funded?

The national healthcare system is composed of the following bodies:

• Social Health Insurance (EsSalud)
• Health Ministry
• Regional and Local Governments
• Health of the Armed and Police Forces

The healthcare system is financed through the Government.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

The public and private healthcare systems work separately.  

12. Are prices of drugs and devices regulated and, if so, how?

The prices of drugs and devices are not regulated in Peruvian regulation. However, there is an obligation to report the prices to DIGEMID’s Price Observatory.

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

Regarding medicines and devices used by patients in the national healthcare system, the drugs and devices are subsidized by the Government. Private payers only play a part in the sense that the subsidy is financed by taxes that they pay. Drugs and devices used by patients using the private healthcare are paid by themselves directly or with an insurance company.  

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Drugs and devices are dispensed to patients by drugstores and pharmacies with the corresponding Sanitary Authorizations. Regarding compensation, medicines are always purchased in a commercial transaction which is afforded by the Social Health Insurance (when using the national healthcare system) or by the patient if no healthcare system is used.  

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

The pharmaceutical chemist who assumes the technical direction of a pharmaceutical establishment is responsible for compliance with the requirements of the quality of the products that are elaborated, imported, exported, stored, distributed, dispensed or sold in them, as appropriate. Likewise, they are responsible for compliance with the Good Practices that correspond to the establishment and other sanitary regulations in force, as well as that the acquisition or distribution of pharmaceutical products, medical devices and sanitary products is only carried out by authorized establishments.

Finally, while not under any obligation to provide information to the patient, any information that they provide must be accurate with the properties of the product.