Marketing, Manufacturing, Packaging & Labeling, Advertising
The key facts about marketing, manufacturing, packaging & labeling, and advertising in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview, question 3.
2. What is the authorization process for the marketing of generic versions of these products?
Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview, question 3.
3. What are the typical fees for marketing approval?
Please refer to Chapter 1: Regulatory, Pricing, and Reimbursement Overview, question 4.
4. What is the period of authorization and the renewal process?
The period of authorization for pharmaceutical products is five (5) years. The renewal process follows the same pathway as the marketing authorization but with minor requisites upon ISP request.
For imported products, our regulations require that the application for renewal be submitted together with the Certificate of Pharmaceutical Product, Registration Certification, Sanitary Authorization Certification or the Official certification recommended by the WHO, issued by the sanitary authority of the country of origin and which evidences that the manufacturing or storage facility, as applicable, meets the conditions required by the laws of such country, that the product has sanitary registration and indicating the complete authorized formula and if the sale of the product is subject to any restrictive sanitary regime or control, if applicable.
As per article 55 of S.D. 03/2010, the following conditions must be met in order to obtain the renewal of the sanitary registration of a pharmaceutical product:
(i) Payment of the relevant governmental fee.
(ii) Compliance with observations made for the suspension of the sanitary registration within the timeframe granted for such purpose, if applicable.
(iii) Non-existence of unpaid fines or compliance with other sanitary measures or sanctions imposed by the ISP in relation to the sanitary registration intended for renewal, if applicable.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Resolution No. 381/2012 issued by the Ministry of Health approved the General Technical Standard on the National Pharmacovigilance System of Pharmaceutical Products for Human Use (hereinafter Technical Standard No. 140) that establishes those who are entitled to participate in pharmacovigilance activities and the actions that must be carried out for each of the participants in the national pharmacovigilance system.
For sanitary registration holders, post-approval pharmacovigilance is regulated by Resolution No. 108/2013, which establishes the content and frequency of Adverse Events and Adverse Reactions reports to be reported to ISP.
The holder of a sanitary registration must submit all reports associated with the safety of its products as well as alerts or health problems with their product(s) in other countries to ISP through a platform.
The ISP will request, in qualified cases and through a well-founded resolution, a Risk Management Plan (RMP) for products corresponding to molecules first introduced in the market, biotechnological products and similar products to innovators that already have an RPM.
The RPMs are requested through the resolution of the ISP that approves the product sanitary registration (resolution of approval), for which a period of 60 calendar days, counted from the date of the presentation, is granted.
In relation to Periodic Safety Reports (PSURs), in accordance with Technical Standard No. 140, these should be required for innovator products, in order to strengthen the safety data thereof.
The frequency of the PSURs will be determined according to the date of the first authorization granted to any pharmaceutical company in any country according to the following scheme:
- During the first two years of commercialization, the report must be submitted every six months at the most;
- During the next three years; annually as a maximum; and subsequently;
- Every five years at most.
6. Are foreign marketing authorizations recognized?
No. It is mandatory to obtain a local sanitary registration to sell and distribute the product in Chile.
7. Are parallel imports of medicines or devices allowed?
From an IP perspective Chilean Industrial Property Law N° 19.039 recognizes the exhaustion of industrial property rights related to trademarks and patents.
Regarding trademarks, article 19 bis E states that the right conferred by the trademark registration does not enable the right holder to prohibit its use by third parties related to the products legitimally commercialized in any country with such trademark by the holder or with its express consent. In the case of patents, article 49 states that patent for an invention shall not confer the right to prevent third parties from marketing the product protected by the patent, which they may have legitimately acquired after said product has been legally introduced into the market of any country, by the owner of the right or by a third party, with the owner’s consent.
Nonetheless, the import, distribution or sale in Chile of any pharmaceutical product requires a prior sanitary registration or authorization granted by the ISP.
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 promotional activities, S.D. 03/2010 allows to provide information on pharmaceutical products to healthcare professionals who can prescribe or pharmacists who can dispense them. Such information must be on label and in accordance to the information approved for the product within the sanitary registration (except for information on off label indications or dosages where it is disclosed to the professional that they have not been approved in Chile to be used under his/her responsibility), complete, truthful and balanced.
Under S.D. 03/2010 it is forbidden to give incentives in any shape or form such as money, goods, services or others to healthcare professionals responsible for prescribing or dispensing medicines, or to individuals selling them, to encourage the prescription, dispensation or sale of a product over another. Additionally, the sale of pharmaceutical products may not be encouraged by giving incentives in any shape or form to pharmacy staff.
On the other hand, under the Sanitary Code, it is forbidden to provide economic incentives of any nature which may induce any person to prefer the use, prescription, dispensation, sale or administration of one or more pharmaceutical products. Moreover, the Ministry of Health may include in this prohibition some elements of medical use.
An incentive is understood to be any payment, gift, service or economic benefit granted or given to the abovementioned persons, by pharmaceutical laboratories, wholesalers, importers, distributors, pharmaceutical establishments in general or by their representatives, in general, by any person or entity that has an interest in preferring the use of one or more products or devices.
Furthermore, certain industry codes include further restrictions and regulations regarding marketing practices such as gifts, gimmicks, sponsorships, consultancy agreements, travel and entertainment.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The ISP is the entity in responsible for the oversight of manufacturing of medicines and devices in Chile.
The manufacturing process of pharmaceutical products is regulated by S.D. N° 03/2010. Article 108 of S.D. No. 03/2010, states that every production laboratory must comply with the rules contained on the Good Manufacturing Practices. Good Manufacturing Practices regulations are approved in Chile by Technical Rule N° 127, issued by Decree No. 28 in 2012 of the MOH and later modified by Decree N° 159 of the MOH in 2013.
According to article 112 and 167 of S.D. N° 03/2010, the ISP may inspect any facility of a production laboratory to verify its functioning conditions in connection to the regulations and Good Manufacturing Practice.
Additionally, every holder of a sanitary registration shall evidence that the manufacturing of the pharmaceutical product, whether local or foreign, meets the concept of quality assurance in the sense of accrediting that manufacturing and analysis methods are validated and lead to obtaining products in compliance with quality requirements, set forth in the sanitary registration in accordance to Good Manufacturing Practices.
The manufacturing of pharmaceutical products is inspected by ISP based on the content of Resolution N° 1290 of April 2016, which approves the “Guideline for Inspection of Public Health Institute”.
For medical devices, the regulations are established in Supreme Decree N° 825/98.
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?
Yes. Good Manufacturing Practices regulations are issued and based upon the internation recommendations set forth by the WHO.
11. What is the inspection regime for manufacturing facilities?
The inspection regime is regulated in Technical Rule N° 127.
The areas regulated are, in general, the following:
– Quality assurance.
– Good Manufacturing Practices.
– Sanitization and Hygiene.
– Qualification and Validation.
– Recall of products.
– Manufacture and analysis by contract.
– Self-inspection and quality audits.
– Staff hygiene.
– Good practices in production.
– Good practices in quality control
There is also a long standing guideline for inspection of GMP, issued by the ISP in 1997.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Our regulation does not cover or mention the possibility for manufacturing facilities to be open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA. Nonetheless, manufacturing facilities are inspected and certified by foreign authorities such as EMA and Anvisa. There are also cooperation agreements signed by the ISP with FDA and with the Pacific Alliance countries for collaboration in sanitary registration and GMP certification of chemically synthesized products.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Technical Rule 147 of Good Storage and Distribution Practices for warehouses and deposits of pharmaceutical products for human use, approved by Decree N° 57 issued in February of 2013 by the MOH, sets forth the requirements for storage, packaging, and handling of medicines.
In general, Technical Rule N°147 set forth requirements for storage of pharmaceutical products in matter such as (i) facilities and installations; (ii) requirements for storage; (iii) Returned products; (iv) Dispatch and transport; and (v) Recall.
Additionally, it regulates the distribution of pharmaceutical products in matters concerning (i) organization; (ii) staff; (iii) quality system; (iv) storage and warehouse; (v) vehicles and equipment; (vi) transport containers and labeling of containers; (vii) Dispatch and reception; (viii) Transport and products in transit; (ix) Documentation; (x) Complaints; (xi) Recall from the market; (xii) Returned products; (xiii) Falsified pharmaceutical products; (xiv) import; (xv) contract services; (xvi) Self-inspection.
Exempt Resolution 1422 issued by the ISP in 2014 sets forth the amended Guidelines for Inspection of Good Storage and Distribution Practices.
14. What information must be included in medicine and device labeling?
Pharmaceutical products in General:
Pursuant to the requirements set forth in S.D. 03/2010, the label of the secondary packaging of a pharmaceutical product shall be in Spanish, in clearly visible letters, and is required to include at least the following information without any advertising or promotional texts.
- Name of the pharmaceutical drug.
- Pharmaceutical form and dosage unit in the case of mono-drugs.
- Unconventional release pharmaceutical forms shall be indicated as such on the packaging material, as stated in the corresponding registration.
- Number of dosage units.
- Formula composition: quantitative and qualitative list of active ingredients and excipients.
- Name and address of the holder and the manufacturing laboratory, packer or importer, as appropriate.
- Route of administration.
- Approved retail conditions indicated with the appropriate abbreviation or full text.
- Expiry date. Furthermore, the included or recommended solvent shall also be required to be indicated in the case of extemporaneous preparations, as well as the effectiveness period after reconstitution, if applicable.
- Registration number given by the Institute, preceded by the following acronym “Reg. I.S.P.” (Institute of Public Health registration).
- Product code. Imported finished products shall keep the original code.
- Storage and conservation conditions.
- Incorporation of the caption, “More information on www.ispch.cl”, and others as set forth in article 87, if applicable.
- Any other information specially and additionally required hereunder or deemed necessary by the Institute upon registration or later.
Secondary packaging of bioequivalent product must include the “bioequivalent isologo”.
The primary packaging shall be required to include at least the information described in items 1, 2, 7, 9, 10 and 11 in the preceding article.
The ISP issued in 2014 and instructive guideline for labelling of pharmaceutical products.
Regulated medical devices must include in their labels the specific information set forth in the Chilean Official Norms (NCh) as made applicable in their respective implementing decrees.
In general, they must include, in Spanish the following minimum information:
- Name of the product.
- Intended use
- Name and address of the manufacturer.
- Name and address of the distributor in Chile.
- Expiration date.
- Sterilization method, if the product is sterile.
- Lot number.
- Storage conditions.
- Quantity of product in package.
- Indication if product is of single use, if applicable
Non-regulated devices, are not subject to such provisions, but general consumer protection rules shall apply, under Law No. 19,496 Consumer Protection Act (CPA). In this regard, please note that, according to the CPA, basic commercial information of the products, its identification, instructions of use, warranty and promotion/advertising must be made in Spanish language, in local currency (Chilean pesos), and using the official weight and measurement system (metric system).
Regarding the specific labeling of the product, it is necessary to include the identification of the products in Spanish (although it is acceptable for such information to also be provided in a different language, in addition to Spanish). Moreover, any other information set forth in the labels and/or use guides/user manuals must also be included in Spanish.
Please note that all the information mentioned above can be added to the device by means of a label sticker.
15. What additional information may be included in labeling and packaging?
Pharmaceutical drugs packed as medical samples shall be required to bear the caption “MEDICAL SAMPLE NOT FOR SALE” (in Spanish) in both the primary and the secondary packaging in indelible ink, in a clear and visible manner.
The labels shall be required to be printed or adhered to the outer surface of the package without being in contact with its contents. Arial or other similar straight fonts shall be used for labelling purposes, in a minimum size of 6.
The graphic label of imported finished pharmaceutical products may exceptionally contain texts in other languages in addition to Spanish, provided that the text authorized by the Institute is not modified.
In addition to the information described in question 14 above, pharmaceutical products intended for direct sale shall be required to include the following details:
- Regular dosing instructions for each indication as authorized in the corresponding registration.
- Any warnings as deemed necessary for safe and effective use of the product, indicating contraindications, interactions and adverse reactions if applicable as determined by the Institute upon granting the sanitary registration.
- These products may be presented in dispensers provided that each blister or strip is placed within an insert or other unit disclosing the full text of the caption approved for the secondary packaging and the patient information leaflet, if not enclosed.
Also, the holders of sanitary registrations may include in the label of pharmaceutical products, the markings or language related to industrial property rights (trademarks and patents) as required by law to exert the rights therein conferred.
16. What items may not be included in labeling and packaging?
S.D. 03/2010 expressly states that advertising or promotional texts may be included in the label of pharmaceutical products.
According to the general rules under CPA, the information included in the products, labels, packaging, advertising of goods and services must be capable of verification and shall not contain expressions that mislead or deceive the consumer.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Pharmaceutical prescription drugs -.i.e. with condition of sale under simple, retained or official prescriptions- cannot be advertised nor be subject to other activities to make the product known. Prescription drugs can, however be informed and promoted directly to the prescribing physician or the dispensing pharmacist.
Pharmaceutical products which are authorized as direct sale pharmaceutical products (OTC) can be advertised to the public. Nevertheless, the advertising must be previously approved by the ISP.
The advertising may only reproduce, totally or partially, the content of the patient information leaflet and labelling, as approved in the respective sanitary registration. Also, it may only refer to the therapeutic recommendations approved by the ISP in the sanitary registration and, in no case, may include titles, figures, indications, effects or other information not in conformity with the sanitary registration.
For devices, there is no specific regulation on advertising and marketing of medical devices. Therefore, general rules under CPA must be taken into consideration.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
As per the provisions set forth in the Sanitary Code, the commercialization of pharmaceutical products is limited only to pharmacies and other authorized facilities duly authorized by ISP.
In connection with the display of pharmaceutical products in pharmacies, pursuant to the Sanitary Code it is possible to deploy shelves, dispensers or other similar devices, which can be used solely for the exhibition and sale of OTC products. It would be possible to display the product itself, the empty package, as well as other devices with images or mock-ups that represent it. To this aim, pharmacies must have an exclusive and defined area inside the establishment which allows customers to have immediate access to it.
With regards to the possibility of delivering pharmaceutical products via post, please consider that, as stated above, since the commercialization of pharmaceutical products is limited only to pharmacies and other authorized facilities, it follows that the dispatch of products must necessarily be performed exclusively from such locations. Furthermore, these facilities require a “brick-and-mortar” establishment as the authority, for its installation, will require the location of the facility and the legal documents that accredit the property over of the same.
The shipping of the products will be mediated by means of an specific delivery service, such as postal offices.
In addition, the dispatch of pharmaceutical products will require the approval of the technical director of the pharmacy or the respective authorized facility. Moreover, in accordance to article 129 A of the Sanitary Code, one of the responsibilities of such technical director at the pharmacy is to carry out or supervise the proper dispensing of pharmaceutical products, in accordance with the terms set forth in the prescription, to inform personally and to promote their rational use, absolving the queries made by users.
For devices, there is no specific regulation or restriction in this regard.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
For pharmaceutical products, this kind of advertising is allowed solely for OTC pharmaceutical products subject to previous approval granted by the ISP.
If the ISP approves this kind of advertising, then the CPA rules shall be taken into account: any commercial communication addressed to consumers by email must clearly indicate: (i) the identity of the sender, (ii) the subject, and (iii) a valid form to request the suspension of these communications (i.e. unsubscribe).
Furthermore, Article 28 B of the CPA provides that commercial communications must grant an “opt-out” mechanism, as recipients of commercial communications by electronic means shall always have the right to request that any such communications cease, through easily accessible means available in Spanish. Thus, if a consumer chooses to opt-out the supplier must suspend any further communication.
For devices, there is no specific regulation or restriction in this regard and the general rules of the CPA shall apply.
20. May medicines and devices be advertised or sold directly to consumers?
For pharmaceutical products it will depend on their approved sale condition (prescription medicines or OTC medicines). In this regard, only OTC medicine can be advertised and sold directly to consumers only in pharmacies or other duly authorized facilities. However, all advertising of OTC medicines must be previously approved by the ISP.
For devices, there is no specific regulation on advertising and marketing of medical devices. Therefore, general rules of the CPA shall apply.
21. How is compliance monitored?
Through inspections carried out by the ISP as a result of its control plan or inspections from ISP originated by third-party complaints.
22. What are the potential penalties for noncompliance?
Please refer to Chapter 1 No. 9. In cases of repeated infringements fines can be duplicated.
Additionally, the ISP can shut down the location or building where the infringement is committed, prohibit its operation, revoke the permits or authorizations granted, suspend distribution of products, among other measures (Section 174 of the Sanitary Code).
In the case of advertising please consider that the sanitary registration of a product may be suspended in the information of advertising or medical promotion is found as non-corresponding to the information approved for the sanitary registration of the product. Any non-conforming advertising or information to the professionals may be also suspended by the ISP who can issue and order for the immediate ceasing or withdrawal of the advertising.
Finally, additional to the registration holders, any individual or entity participating in the divulgement of unauthorized publicity will be liable and may be subject to sanctions as above indicated.