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Upholds law on processing fees for drugs and cosmetics: Here’s what’s changing



The Legislative Assembly's Finance Committee approved a favorable opinion on the new drug tariff law.  / Legislative Assembly.

The Legislative Assembly’s Finance Committee approved a favorable opinion on the new drug tariff law. / Legislative Assembly.

The Finance Committee of the Legislative Assembly approved on Monday this week a favorable opinion on the special law on prices of services of the National Directorate of Medicines (DNM). The law would increase most of the fees the agency charges drug companies.

The fee increase will result in DNM collecting an additional $4.6 million in the first year, $5.6 million in the second year, and $7.1 million starting in 2026.

National Pharmaceutical Director General Noe García Iraheta adjusted some of the tax rates proposed by Health Minister Francisco Alabi after receiving input from pharmaceutical companies. And MPs fully accepted the new DNM proposal.

El Salvador’s Chemical and Pharmaceutical Industry Association (Inquifar) and the Salvadoran American Chamber of Commerce (Amcham) also called for a 12-month period for the tax rate to be implemented and for it to be phased in. Lawmakers approved an expiration date of January 2024, as proposed by DNM.

The law also establishes fees for registration services for chemical products used in medical devices and other health technology, pharmaceutical, cosmetic, sanitary, equipment, and controlled substance industries.

Similarly, DNM charges to perform laboratory analyzes for quality control, import/export permits, advertising or promotional permits, regulatory product approvals, clinical trial evaluations, registration of facilities including pharmacies, audits, etc. Rates are also regulated. service.

service current rate Suggested rate Approval rate
Biological, biotech, vaccines and innovative health registries $352-$536 $3,000 $1,500
Generic Bioequivalence Health Registry $352-$536 $3,000 $1,000
Other medicines 400 dollars 600 dollars 600 dollars
Complex modifications: evaluation of in vivo or in vitro bioavailability and bioequivalence studies $25-$250 $420 $420
Changes in therapeutic indications or co-marketing approvals $25-$250 $420 $120
Moderate complexity changes $25-$250 $120 $120
Changes in Experts or Additional Representatives with Records Affected by Changes $25-$250 $0.60 $0.60
Other changes to the registry $25-$250 $48 $48
Annual renewal of marketing authorization $50-$75 $24 $45
Annual maintenance fee for market monitoring not exist $120 100 dollars
Release or exemption of batches of biological products not exist $96 100 dollars

cosmetics and hygiene products
service current rate Suggested rate Approval rate
Obtain health registration, manufacturing and sales approval, and renewal $75 and $25 updates $240 $240
Changes in Expert or Representative 1 Records $25 $48 $48
Additional charges for registration due to changes $25 $0.60 $0.60
Other later changes $25 $48 $48
Annual renewal of authorization or marketing $25 $12 $25
Annual maintenance fee for market monitoring (registered products sold domestically) not exist $48 $35

Source: Diario Elmundo

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