Marketing, Manufacturing, Packaging & Labelling
Legal info on marketing, manufacturing, packaging & labelling in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The authorization process for the marketing of new drugs, biologics, medical devices, OTC and other medicinal products is through a marketing authorization as detailed in question 3 of Regulatory, Pricing and Reimbursement.
2. What is the authorization process for the marketing of generic versions of these products?
The authorization process and requirements for the marketing of generic versions is the same, the only difference is in the labeling requirements
3. What are the typical fees for marketing approval?
- Official fees foreign manufactured pharmaceuticals US$2,258.41
- Official fees local manufactured pharmaceuticals US$904.34
- Official fees foreign manufactured generics US$565.21
- Official fees local manufactured generics US$510.51
- Official fees generic drugs included in the basic pharmaceuticals chart US$452.17
4. What is the period of authorization and the renewal process?
The validity of a marketing authorization for a pharmaceutical or medical device is 5 years. The automatic renewal proceeding applies in the case of products that during their period of validity have not had changes or modifications in their intended use, as well as in their quality, safety and efficacy; and that they have not been subject to suspension by the Health Authority.
The holder of the marketing authorization must file an automatic renewal request at least ninety (90) days before the expiration date of the health registration.
The marketing authorization is renewed within 15 working days for a 5-year period.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The holders of a marketing authorization for medicines that are marketed in Ecuador have the obligation to:
- Notify the National Pharmacovigilance Council of all suspected adverse events, which occur in the country, or in another country where clinical trials are conducted and/or the product is marketed.
- Keep a detailed record of all suspected adverse events, which occur in the country, or in another country where clinical studies are conducted and/or the product is marketed;
- Submit safety reports every six months for new medicines (new API in Ecuador), which will allow the rectification or ratification of indications, contraindications, adverse effects, and to obtain relevant information on the safety and therapeutic efficacy of the product. When a negative response is detected that exceeds the established safety limits, it must be reported immediately to the National Pharmacovigilance Council;
- Implement modifications in the technical sheet, the labeling and the prospectus or insert as required by ARCSA.
The establishments of medical devices and in vitro diagnostic biochemical reagents for human use that produce, import, export, distribute, market, store, dispense and sell such goods have the following obligations:
- Collaborate with the National System of Technological Surveillance as to the identification, prevention and notification before ARCSA, about the risks associated with medical devices;
- Notification of any suspected adverse events and adverse incidents to the National Pharmacovigilance Council;
- Keep a detailed record and a physical or digital file system of all the suspected adverse events and adverse incidents for at least 5 years.
- Continuous staff training in technological surveillance.
6. Are foreign marketing authorizations recognized?
Homologations are allowed for medicines, which means official recognition of the marketing authorization granted by health authorities of the countries whose regulatory agencies for medicines have been certified by the Pan American Health Organization (PAHO) / World Health Organization (WHO) as Regional Reference Authorities, as well as those marketing authorizations granted by the health authorities of the United States of America, Canada, Australia, Japan, the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of South Korea.
For a homologation to be approved in medicines, it must originate in the aforementioned countries, be part of the basic medicines required by the country (National Table of Basic Medicines) and the medicine has not been registered in the country or there are less than 5 records of the active principle, concentration and pharmaceutical form in the country.
LIST OF APPROVED COUNTRIES FOR THE HOMOLOGATION PROCESS
|Regulatory agencies qualified by the PAHO/ WHO||INVIMA,
|Marketing authorization or its equivalent|
|United States of America||FDA||United States of America||Marketing authorization or its equivalent|
|Canada||Health Canada||Canada||Marketing authorization or its equivalent|
|Australia||Therapeutic Goods Administration||Australia||Marketing authorization or its equivalent|
|Japan||Pharmaceuticals and Medical Devices Agency||Japan||Marketing authorization or its equivalent|
|Ministry of Food and Drug Safety||Ministry of Food and Drug Safety||Republic of South Korea||Marketing authorization or its equivalent|
|European Medicines Agency (EMA)||European Medicines Agency (EMA)|| All member countries
of the European Community through the EMA*
|Only Certifications of Medicines issued by the European Medicines Agency (EMA) are accepted. Certifications of regular authorities of the member countries of the European Community are not accepted.|
*Member Countries of the European Medicines Agency (EMA): Belgium, Bulgaria, Czech Republic, Denmark, Germany, Austria, Croatia, Slovakia, Slovenia, Estonia, Greece, Spain, France, Finland, Ireland, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Poland, Portugal, Romania, United Kingdom, Sweden.
7. Are parallel imports of medicines or devices allowed?
Parallel imports are prohibited in Ecuador since a marketing authorization is required for the import, sale, manufacturing, import and export of pharmaceuticals and medical devices.
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?
The promotion of medicines and medical devices must be made to the health professionals authorized to prescribe, through a pharmaceutical sales representative. In these visits it is forbidden to grant or offer gifts, prizes, economic incentives, trips and similar, by pharmaceutical establishments dedicated to the manufacture, storage, distribution, commercialization and dispensing of medicines in general, processed natural products of medicinal use and homeopathic medicines.
It is forbidden that scientific, sporting, cultural and other similar events are sponsored with the name of medicines in general, natural medicinal products, homeopathic medicines and medical devices. Pharmaceutical sales representatives are prohibited from all public health services.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The authority responsible for enforcing the regulatory framework in relation to medicines and medical devices is the National Agency for Regulation, Control and Sanitary Surveillance (ARCSA).
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
In Ecuador, the certificate of GMP is granted by ARCSA, after complying with the requirements established in the local GMP Regulations for Pharmaceutical Laboratories, which is based on Annex 1 of Report 32 of the World Health Organization.
In the case of medical devices, the regulation that will regulate GMP is in the process of being approved and the certification will be granted by external organizations that will work in conjunction with ARCSA.
11. What is the inspection regime for manufacturing facilities?
ARCSA is empowered to make on-site visits at any time to inspect premises and verify compliance and can initiate ex-officio legal proceedings to sanction non-compliance. Ultimately, these legal proceedings can result in fines, seizures, the revocation of the marketing authorization and closing of facilities. GMP, stability, labelling standards and all other applicable provisions must be complied with. The marketing authorization holder must have a programme to recall and destroy products that do not meet quality standards.
GMP inspections will be carried out by qualified technical personnel from ARCSA, and eventually, depending on the case, advisors with a specialized technical background but without voting rights can participate.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Inspections are performed solely by ARCSA.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The main requirement is the Good Storage, Distribution and Transportation Practices (GSP/GDP/GTP) Certificate issued by ARCSA.
To obtain it, the company must comply with the following:
- Legal personality;
- Legal representative;
- Equipment and facilities that correspond to the activities developed.
- Operation permit issued by ARCSA.
- Technical advice from a Biochemical Pharmacist employed by the establishment.
- Documentation describing the functions and responsibilities of the staff in the pharmaceutical establishment.
- Standard Operating Procedures (SOPs) according to the activities developed.
- Technical documentation of all activities.
14. What information must be included in medicine and device labeling?
MEDICINES IN GENERAL:
- Name of the product.
- Generic name (DCI)
- Pharmaceutical form.
- Container net content expressed in the International System of Units (SI, from the French Le Système International d’Unités)
- Qualitative-quantitative formula.
- Administration routes.
- Batch number or code.
- Pediatric use if the product requires it.
- Conservation temperature.
- Manufacturer’s name, city and country.
- Date of manufacture and expiration.
- Marketing authorization number.
- Sales specification:
- Under medical prescription.
- Under controlled prescription.
- Restricted circulation.
- Sales price (PVP)
In case of generics it is also mandatory to include the generic name in capital letters, red color, Pantone Red 032 and of a size 20% larger than the brand name of the product.
- Commercial name of the product;
- Container or packaging contents;
- Use indications, where appropriate;
- Warning and precautions of use; the use of symbols is permitted;
- Storage conditions, the use of symbols is permitted;
- Manufacturer’s name, city and country;
- Manufacturing locations, where appropriate,
- Expiration date, where appropriate;
- Shelf life, where appropriate;
- Storage temperature, where appropriate;
- Batch number / series;
- Marketing authorization number;
- Sales price (PVP);
15. What additional information may be included in labeling and packaging?
a. For OTC, the label shall include:
Warning: “If symptoms persist, consult your doctor.”
b. In medical samples, labels must declare:
“Medical Sample, sales prohibited”.
c. Other information; using images or symbols description, where appropriate.
1. “Protect from light”.
2. “This product should not be administered during pregnancy or when its existence is suspected”
16. What items may not be included in labeling and packaging?
Slogans such as: “the greatest choice”, “the most frequently recommended”, “the best”, “totally reliable”; “the most effective”, among others not scientifically demonstrable.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Goods that require prescription cannot be advertised.
General publicity for OTC medicines and devices is possible with prior authorization from the Health Ministry (HM).
The advertisement must indicate the therapeutic indications or uses of the product. In case of advertising in audiovisual and printed media (such as brochures, flyers, leaflets), the advertising content should contrast its color with the background of the advertisement.
The advertising permit will be valid for 6 months under the conditions on which it was approved.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
The HL establishes that all medicines including OTC goods must be sold in authorized establishments, holding the corresponding permits.
Medicines and devices can be delivered by entities holding the necessary permits (GSP/GDP/GTP).
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
The HM is in charge of monitoring this type of publicity and checking that they have all the corresponding permits. The HM also monitors that the advertising is within the authorization parameters. If there is a breach, the advertising authorization can be suspended and fines imposed.
20. May medicines and devices be advertised or sold directly to consumers?
Only OTC can be advertised to the general public, with prior approval. All medicinal goods need to be sold in facilities holding the necessary permits
ARCSA permanently controls all aspects of medicines and medical devices.
21. How is compliance monitored?
It is also common that competitors raise claims for non-compliance with ARCSA.
22. What are the potential penalties for noncompliance?
The sanctions for not complying with the advertising rules are the suspension of advertising activities and fines and in certain cases the temporary or definitive closure of the establishment.
In addition, if the breach of the advertising rules deceives consumers and generates a competitive advantage, a fine of up to 10 % of the infringing party’s total turnover in the fiscal year preceding that of the fine, may be imposed by the Superintendence for Market Power Control (SCPM).
Goods that require prescription cannot be advertised.
General publicity for OTC medicines and devices is possible.