Learn more about our medical device and pharmaceutical market at 997556699 or by mail info@pharmaconsulting.pe

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Emergency decree No. 0-26-2020 established various exceptional and temporary measures to prevent the spread of the new coronavirus (COVID-19) in Perú. Our national regulator, DIGEMID, has established the prioritization of several administrative procedures:

• Exceptional authorizations for individual treatment of patients, which grants the bearer authorization to import medicines, biological products, and medical devices.

• Registration of pharmaceutical products related to preventing, diagnosing, and treating COVID-19, and other high-priority diseases as dengue, and Guillain Barré syndrome.

• Registration of medical devices and in-vitro diagnostic medical devices related to preventing, diagnosing, and treating COVID-19, and other high-priority diseases as dengue, and Guillain Barré syndrome.

• Registration of household cleaning products and disinfectants.

Imported cosmetic products that are marketed in the Andean subregion must comply with cGMP according to the new regulations and international standards.

• Examination gloves.

• Surgical gloves.

• Reagent kits for molecular tests (new coronavirus)

• Quick hygiene tests for surfaces.

• Rapid IgG and IgM antibodies tests.

• PCR type molecular biology kits.

• Products for oral and dental hygiene: toothpaste, mouthwashes, rinses.

• Soaps and detergents.

• Household hygiene products.

• Surface disinfectants (active against the new coronavirus)

• Absorbent damp cloths.

• Hand sanitizer.

• Medicinal alcohol solutions.

• Non-sterile mask o face mask.

• Disposable mask.

• Disposable protective mask, non-sterile, N-95 type.

• Single-use gown for patients, non-sterile.

• Single-use gown, non-sterile.

• Reusable patient gown, non-sterile.

• Non-sterile surgical caps.

• Non-slip insole shoes.

Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about product registration in Perú.

Source: DIGEMID

Estimates of the Peruvian Cosmetic and Hygiene Guild (COPECOH) indicate that the market for personal hygiene and cosmetic products would mobilize up to 9.8 billion soles during this year.

The products with the greatest demand, mainly by women, are fragrances, hair products, skincare products, and makeup.

In terms of consumer channels for these products, the preferred ones are retail sales, direct sales, and virtual stores.

• Cosmetics for the skin: makeup, makeup remover.

• Cosmetics for lips: lipsticks, balms.

• Cosmetics for grooming and personal hygiene: soaps, scrubs.

• Nail cosmetics: nail polish, acrylic nail systems, polish removers.

• Perfumery cosmetics: lotions, perfumes.

• Hair cosmetics: shampoo, conditioners, hair dyes.

• Products for oral and dental hygiene: toothpaste, mouthwashes, rinses.

• Products for and after shaving: lotions, shaving cream.

• Products for tanning, sun protection, and self-tanners.

• Depilatories: liquid wax, roll-on wax.

• Products for skin whitening.

• Deodorants and antiperspirants.

Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about cosmetic products registration in Perú.

Source: COPECOH

The National Authority of Pharmaceutical Products, Medical Devices, and Health Products has reduced the maximum period of evaluation for the inscription and reinscription of medical devices in the Peruvian sanitary registry.

Medical Devices (MD) Class I, low risk: Up to thirty (30) calendar days.

Medical Devices (MD) Class II, moderate risk: Up to sixty (60) calendar days.

Medical Devices (MD) Class III, high risk: Up to ninety (90) calendar days.

Medical Devices (MD) Class IV, critical risk: Up to ninety (90) calendar days.

Due to this modification to the current regulations, manufacturers and importers are expected to reduce the time to market their products.

All medical device registration applications are subject to review from regulatory authorities. Distributors must wait until formal review and approval are complete to begin importing and selling. Timeframes range from 1 to 6 months. If all goes according to plan, DIGEMID will issue a Directorial Resolution approving your device registration. The registration is valid for ten years.

Learn more about MD registration in Perú and contact us at 997556699 or by mail info@pharmaconsulting.pe

The president of the Pharmaceutical Industries Association (ADIFAN), José Silva, explained that Peruvian laboratories are at disadvantage compared to foreign manufacturers who are favored by tariff exemptions.

Due to this situation, Peruvian laboratories manufacture less quantity of medicines, causing up to 70% of medicines in Perú to be imported and only the remaining 30% to be national production.

In this regard, the National Institute of Research and Statistics (INEI) has established that the production of the national pharmaceutical industry has been declining from 2013 until 2017 when it grew by 10%.

The president of ADIFAN said that Perú imports medicines for an amount of USD 1.3 billion and only exports USD 69 million.

Source: Gestión

The Peruvian government published the regulation of the Emergency Decree No. 007-2019 that guarantees access to generic drugs, biological products, and medical devices as an essential part of the right to health.

• Aminotriptiline

• Amlodipine

• Amoxicillin

• Amoxicillin/clavulanate

• Atorvastatin

• Azithromycin

• Beclometasone

• Captopril

• Carbamazepine

• Cefalexin

• Clindamycin

• Clonazepam

• Clorphenamin

• Clotrimazole

• Enalapril

• Phenytoin

• Fluconazole

• Fluoxetine

• Glibenclamide

• Ibuprophen

• Loratadine

• Losartan

• Metformin

• Naproxen

• Omeprazole

• Acetaminophen

• Prednisone

Learn more about the Peruvian pharmaceutical market at 997556699 or by mail info@pharmaconsulting.pe

Pharma Consulting warns the general public about the danger of acquiring pharmaceutical products, medical devices, and other health products in unauthorized establishments or through advertisements on social networks and e-commerce websites.

We express our concern about an increase in advertisements for products that lack the registration required, advertisements that proclaim unauthorized benefits, or therapeutic properties that deceive consumers and promote self-medication. The products commonly marketed in social networks and internet ads as “fat burners”, “weight loss pills”, “hair loss prevention pills”, “sweeteners”, “energizing” drinks, among others.

The use of these illegal or adulterated products poses a serious risk to health since in many cases they are fakes or mixtures with chemical substances not suitable for human consumption.

Pharma Consulting reminds consumers not to be surprised by advertisements for products that offer unrealistic benefits.

Contact us at 997556699 or by mail info@pharmaconsulting.pe to learn more about product registration in Perú.

Source: DIGEMID

The Directorate of Medicines, Supplies, and Drugs – DIGEMID, issued a list of medical devices that can be marketed directly to end-users. In order to acquire a particular product, users must present a medical prescription, if required.

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) biomedical equipment, only to be sold to health professionals and institutions that provide health services (IPRESS).

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to health professionals and institutions that provide health services (IPRESS).

Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical risk) medical devices, only to be sold to patients, upon presentation of a medical prescription.

Class I (non-sterile, low risk) only to be sold to commercial establishments.

Self-tests, reagents, and laboratory equipment.

Contact us at 997556699 or info@pharmaconsulting.pe to learn more about medical device registration.

Source: DIGEMID