13.5 C

New DNM charges for processing of pharmaceuticals, cosmetics and medical supplies



The new “Special Law on Prices of Services of the National Directorate of Medicines (DNM)” will affect the authorization procedures and other procedures related to drugs, cosmetics, chemicals and medical products, and the amount recovered by the agency will be tiered. The amount is expected to increase to a maximum of 20 million yen. 72%.

At current rates, DNM expects to generate $9,972,241 in revenue for pharmaceutical companies, drug stores, and laboratories. With the project approved yesterday, he will earn $14.6 million in 2024. $15.5 million in 2025. The agency says $17 million will be provided starting in 2026.

A favorable opinion on the new special law was approved by the Finance Committee on Monday of this week. The regulation is expected to be approved at the plenary session this Thursday.

“We need to update the tariffs so that the directorate can become self-reliant,” Noe García Iraheta, the National Pharmaceutical Director-General, who readjusted the proposed tariffs after input from pharmaceutical companies, argued before lawmakers. .

The price list is old, but the response time has improved…and to be honest, the process is subsidized. ”
Noe Garcia Iraheta
Director of DNM

new rates.

One of the new fees is the “Annual Maintenance Fee for Market Surveillance.” The fee is $100 for medicines and $35 for cosmetics and hygiene products. $85 for medical equipment and other health technology.

DNM will institute a new $720 fee for a complete audit of best practices for solutions, gauze, cotton, dressings, masks, orthopedic soft products, and personal protective equipment. $720 for this audit in laboratory, clinical and other practices. Audit of remaining devices is $1,500. $180 for manufacturing floor master file review.

This regulation establishes a new $750 fee for laboratory analysis for quality control of hospital medical antiseptic and disinfectant products, surgical sutures, and endotracheal or tracheostomy tubes. $1,000 for surgical masks, particulate masks, scalpel blades, medical adhesive tape, urine collection bags, and condoms or condoms. $1,500 for analysis of medical biosafety suits, needles, catheters, gloves, clothing, and surgical materials and fabrics; $1,200 for other medical equipment and other health technology.

Similarly, there will be a new fee of $750 for laboratory analysis of raw materials for cosmetic and hygiene products and pharmaceutical applications. Batch exemption for biological products, $100. Training $5 per person. Certification test, $60. Chemical registration renewal, $5. Exporter’s permit, transfer or change of authorization or renewal of registration, $6.

Any additional costs incurred will be borne by the company, but we are subject to regulations regarding maximum sales prices (for pharmaceutical products). ”
carmen perez
President of Inquifar

Increment and gradualness.

The new law increases most of the tax rates already existing in the current Decree No. 417, which will be repealed with final approval of the regulations to be voted on today. Some prices have been reduced.

For example, it costs $75 to obtain a cosmetic health registration, rising to $240. It will be phased in, starting at 50% in 2024. 75% in 2025. 100% from 2026.

New maintenance fee rates for health registration renewals and medicines, which will range from $600 to $1,500, will also be phased in to 50% in 2024, 75% in 2025 and 100% in 2026. is.

The above registration changes will increase in price from $25 to $48. The renewal fee remains $25.
Other increased fees include Obtaining a Medical Device Health Registration from $100 to $150 to $1,440, Change from $25 to $150 to $1,440, and Renewal from $20 to $25 to $150. ranging from $1,440.

Laboratory analysis for quality control increases from a range of $108.57 to $1,390 to a range of $500 to $2,200.

The fee for an import permit, currently up to $50, will be reduced to $24, while the fee for a special import permit will be $250.

Similarly, registration and licensing for laboratories that manufacture or package pharmaceuticals and natural products will increase from $550 to $1,440. For chemistry, hygiene products, or cosmetics labs, the price increases from $550 to $960. Prices range from $450 to $600 from drug stores and storage centers. $300 to $400 at a pharmacy. first aid kits and hospital pharmacies, $250 to $300; Supermarket dispensers go from $200 to $150. Automatic dispenser, $300 to $150. Over-the-counter drug dispensers for markets, stores, and other public use will increase in price from $25 to $120.

Annual renewals of registrations, transfers or changes in authorizations for the activities or infrastructure of laboratories that produce pharmaceuticals and natural products will increase from $350 to $720. Although it is decreasing in over-the-counter drug dispensers and vending machines in supermarkets, the same procedure is increasing in chemical, sanitary and cosmetics manufacturers, pharmacies, and medicine cabinets.

Bill on Service Fees of the National Directorate of Medicines (DNM)

1.- Audits range from $720 to $1,500

The new full audit fee for the solution and gauze is $720. The remaining devices cost $1,500.

2.- Laboratory analysis

Equipment, cosmetics, hygiene products, homeopathy, and nutritional supplements cost between $750 and $1,500.

3.- Exemption

Free medical services, ISSS and orphan drug procedures (those not present in the local market) are exempted.

4.- Maintenance fee

Surveillance maintenance charges are created for different products (e.g. medicines).

5.- Step by step

Cosmetics registration fees, renewal fees, and pharmacist maintenance fees will be applied in stages.

Source: Diario Elmundo

Subscribe to our magazine


━ more like this

Berlin plans to ban Chinese components from its telecommunications network

There is no evidence that Chinese companies in Germany are spyingIn the coming week, the German government is expected to resolve the last dilemmas...

Berlin plans to ban Chinese technology components from its telecommunications network

There is no evidence that Chinese companies in Germany are spyingIn the coming week, the German government is expected to resolve the last dilemmas...

Miami’s historic game, which dumped as many as 70 points on Denver

NFL Week 3 RecapMiami football players played with Denver in week 3 of the NFL League, as they defeated it with a score of...


Please enter your comment!
Please enter your name here