EMA offers labeling flexibilities for COVID therapeutics

Regulatory NewsRegulatory News | 16 March 2021 |  By 

After providing flexibility on labeling requirements for COVID-19 vaccines last year, the European Medicines Agency (EMA) on Monday offered guidance on when those flexibilities could be applied to COVID-19 therapeutics.
The temporary labeling and packaging flexibilities for COVID-19 vaccines are outlined in a memorandum of understanding between the European Commission and EU member states and a questions and answers guidance from EMA. The flexibilities include allowing COVID-19 vaccines to be distributed with English-only packaging and allow for English-only printed package leaflets in most member states. (RELATED: EMA clarifies label flexibility for COVID vaccines, Regulatory Focus 3 December 2020).
Now, in a new questions and answers guidance, EMA explains that the same flexibilities may be applied to COVID-19 therapeutics under certain circumstances.
“These flexibilities are exceptional and may not be appropriate or necessary for all other products with a COVID-19 claim. To avoid any misuse, the full application of these flexibilities will not be automatic,” EMA says.
To qualify for the labeling flexibilities, EMA says the product must be for prescription use and indicated to treat COVID-19 or its complications.
“Any medicine for self-administration should not benefit from these additional flexibilities, particularly the language exemptions,” EMA says.
EMA adds that the labeling flexibilities will typically only apply to new medicines and not to extensions of therapeutic indications for already authorized medicines unless the need for flexibility is fully justified. The agency explains that marketing authorization holders (MAHs) of centrally authorized products should already have systems and facilities in place to handle any challenges involved in updating and translating labeling.
Not all medicines will qualify for the labeling and packaging flexibilities. EMA says that the flexibilities are reserved for medicines with an important role in tackling the pandemic and that medicines accepted for rolling review will be considered eligible.
That said, EMA says that whether the flexibilities are appropriate for a given medicine will be assessed on a case-by-case basis and “will be considered in the context of the individual submissions of the company and may be adapted as appropriate."
The flexibilities are temporary in nature and “MAHs will ultimately have to comply with the full labeling and packaging requirements,” EMA says. As such, applicants are expected to provide details of how long the exemptions will be needed.
“The duration of the exemptions may be limited to certain time period, number of batches in the context of the pandemic, and will be determined on a case-by-case basis,” EMA says, adding that applicants should provide an estimate for how long a product would be delayed if no exceptions to standard labeling requirements are allowed.


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