FDA’s novel excipient pilot program is open for candidates

CDER (Center for Drug Evaluation and Research) recently launched a new voluntary Novel Excipient Review Pilot Program, intended to allow excipient manufacturers to obtain FDA review of certain ‘novel excipients’ prior to their use in medicinal products. This pilot is geared at fostering development of excipients that may be useful in scenarios in which manufacturers and originators have difficulties in using existing excipients.

This pilot will initially be available for novel excipients that

(1) have not been previously used in FDA-approved drug products, and
(2) do not have an established use in food.

For excipient manufacturers, the pilot consists of two stages: The first stage is to provide a high-level overview of the ‘novel excipient’, with stage two providing a full data set including toxicology and quality data.

What is a ‘novel excipient’?

Excipients are inactive ingredients that agencies review as a component of a finished drug. This could be in a new drug application but also in a generic drug application. These inactive ingredients can work to stabilise medications and help the body absorb the active ingredients. Other areas of use are for flavouring, colouring or coating of the medicinal product. ‘Novel excipients’ are any excipients that are not fully supported by existing safety data yet.

Why this pilot then?

Excipients can certainly help with delivering drugs to where they are needed in the body. They can also play a part in helping patients to tolerate medication, but sometimes this is associated with risks. Triggering allergies for example is one area of concern. Hence regulators evaluate excipients for safety and stability as early as possible, so as not to negatively impact any medicinal product delivery to the patients. With this pilot, the FDA opens a pathway to evaluate ‘novel excipients’ that could provide important public health benefits. Submissions are voluntary, allowing excipient manufacturers to obtain early review of certain ‘novel excipients’ prior to their use.

How are ‘novel excipients’ selected?

The FDA will accept a limited number of ‘novel excipients’ for this pilot. Selection preference will be given to proposals demonstrating

• a potential public health benefit – one example being excipients promoting development of new therapies for serious diseases.
• potential to improve characteristics that may lead to new drug development
• likelihood of timely delivery of complete package ready for assessment.

In summary

The ‘novel excipient’ pilot will work to promote development and use of new excipients, where using existing excipients is challenging or not possible. Its success will be measured with the review and identification of ‘novel excipients’ that improve drug development including new medicinal products, to be introduced to the patients for an unmet medical need.

Subsequent Recognition Procedure: A new kid on the block?

In Europe, Marketing Authorisation Applications (MAAs) can be submitted following different procedures. If Marketing Authorisation Holders (MAHs) desire access to all member of the European Economic Area (EEA) using a single procedure, the Centralised Procedure (CP) is the way to go. The EEA includes the members of the European Union plus Norway, Iceland and Lichtenstein. For applications on a country by country basis the National Procedure (NP) would be appropriate, the most common procedure also used worldwide. In Europe though there are two additional procedures in place to accommodate specific EEA requirements: the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP). Both procedures try to eliminate costly approval for medicinal products that are already approved in another member state.

The MRP procedure should be used where a medicinal product has already received a Marketing Application (MA) in a Member State (MS) at the time of application.

The DCP procedure should be used where a medicinal product has not yet received a MA in a MS at the time of application.

Both MRP and DCP are procedures to obtain MAs in more than one MS. It is open for all applications not falling under mandatory scope of the Centralised Procedure. One of the most important aspects for both MRP and DCP is that for both procedures, MS’s rely on each other’s scientific assessment.

But now there seems to be a new kid on the block, the Subsequent Recognition Procedure (SRP) supporting veterinary marketing applications.

When can it be used?

The Subsequent Recognition Procedure may be used after completion of a first Mutual Recognition Procedure or a Decentralised Procedure for the recognition of a Marketing Authorisation by additional Member States for the same veterinary medicinal product. The SRP can be used in MS’s, which were not included in the original MA or in Concerned Member States (CMS) where the MA was withdrawn.

At the end of a successful SRP, the “new” CMS will either recognise the MA of the product with the same SPC, labelling and package leaflet that were approved in the earlier MRP or DCP, or a new variation will be introduced in the “old” CMS to implement any requested changes linked to Potential Serious Risk (PSR) concerns. Minor editorial changes can be submitted with the first variation after the closing of the procedure.

Is the SRP really new?

In short: No. The SRP could also be referred to as the Repeat-Use Procedure (RUP), which was the common term previously used before implementation of Regulation 2019/06/EC.

What is required?

According to the Council of the European Union, Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products, dated 08/June/2018, the following administrative information referred to in Article 7(1)(a) should be submitted

  • Applicant such as name and address of manufacturing sites;
  • Identification of the veterinary medicinal product such as product name and substance;
  • Product information such as summary of product characteristics (SmPC) and proposed text for packaging;
  • Other information such as list of countries the MA has been authorised in.

For the SRP, additional information is required:

a) A list of all decisions granted, suspending or revoking MAs concerning this veterinary medicinal product;
b) Information on the variations introduced since the MA by DCP (Article 46(5)) or MRP(Article 48(5a)) was granted;
c) A summary report on pharmacovigilance data.

In summary

With SRP, are we introducing another submission type for veterinary medicinal products? Not quite as the Repeat Use Procedure was covering most of the aspects of SRP. There are however a few areas to notice such as outlined in Article 48a of the “Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products”. One aspect of interest is the handling of the MA in case of disagreement between respective member states. More another time.

Digital Transformation for the benefit of the equine world

Digital transformation (DX) is the adaptation of digital technology, the transformation of services and business processes to replace manual or outdated non-digital processes. However, DX is much more than the integration of digital technology. DX might even move technology and processes to the edge of what is currently possible, the last mile where technologies meets, where process collide. An area for any business destined for improvements.

But what has that to do with the equine world?

DX takes place in other areas, not just high-tech; the veterinary world is just one example. Technology has been used to monitor performance during horse racing for years, but with DX in addition, opportunities seem endless to improve equine health and wellbeing. Although it might mean to walk away from more traditional thinking or long-standing processes, there are advantages that can only be realised by taking DX seriously. DX might be simply a piece of technology such as a sensor, or it could be a piece of software to monitor heart rate or data analysis presented in real time. The ability to adapt quickly is one of the challenges in business, but also one that can be addressed by DX; the equine world is no exception.

There are only a few animals close to humans that represent beauty, agility, strength and sometimes freedom quite in the same way as hoses do. Although the place and role of horses has changed over hundreds or even thousands of years, horses have demonstrated their adaptability from farm worker to athletes. But did technology advance with them in a similar way?

Example: pressure sensors

For a long time, humans “experimented” with different types of saddles, but without taking into account the horse’s comfort, health and agility. The somewhat heavy and more sturdy western saddle for example could weigh up to 30kg, in contrast the traditional English saddle is lighter and more flexible. However, most saddles were made with the rider in mind; they were designed to provide comfort for the rider and the ability to control the horse with ease, sometimes for going long distances. But what about the horse?

With DX taking place, new technology in the form of pressure sensors has been developed, allowing measurements with greater accuracy and in a timely manner. At long last, it will be possible to determine whether a saddle fits too tightly putting unnecessary pressure on the horses back and making it uncomfortable; or checking the saddle is only using a fraction of its surface creating undesirable effects. However you look at it, getting a better understanding of the optimal fit will benefit the rider as well as the horse leading to a much better partnership.

Example: 3D printing

Another example is 3D printing. The 3D printing process creates a three-dimensional “object” by building successive layers of “objects” produced for example by CAD (computer-aided design) drawing or an MRI (Magnetic Resonance Image). 3D printing is already widely used in healthcare for example by dentists to create crowns in a fraction of the time it takes a lab relying only on manual labour. The flexibility of 3D printing allows the alteration of the final “object” more simply. Personal devices are another good example for 3D printing as these devices can be matched to each patient’s physique.

But how might 3D printing benefit the equine world?

3D printing could be used to create bespoke horseshoes where accuracy is of higher importance than speed of application. 3D printing would enable a farrier to create horseshoes on the fly with minor alterations possible even on the day. Perfectly fitted, lightweight racing shoes made (for example) from Titanium are already been produced. Other areas of application would be for bone substitutions, a welcome change to the historic euthanasia in the case when a horse suffers an unfortunate bone fracture.

In summary

Digital Transformation (DX) is not only happening in high-tech companies, it will have an impact on many businesses. DX will help in many areas such as Regulatory Information Management via sensors to 3D printing by expanding via the use of leading-edge technology and processes to improve everybody’s life, including that of horses.

Transitional arrangements for Regulation (EU) 2019/6 for Veterinary Medicinal Products

On 19/July/2021 the CMDv released document EMA/CMDv/181154/2021 entitled “Transitional arrangements for the entry into application of Regulation (EU) 2019/6 for veterinary medicinal products registered under national, mutual recognition and decentralised procedures”. CMDv has prepared this document to assist Marketing Authorisation Holders (MAHs) as well as National Competent Authorities (NCAs) in the management of the transition from Directive 2001/82/EU to Regulation (EU) 2019/6. The CMDv provides this guidance mainly for the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP).

The release of the CMDv document follows publication 2021/C 274/02 from the European Commission “Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5‐year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6”, which clarifies some practical steps, mainly for the centralised procedure with some aspects also applying to the national procedure.

What do these documents contain?

Both documents are addressing MAs for Veterinary Medicinal Products (VMPs) that require renewals, either under the current Directive 2001/82/EU or under the new Regulation (EU) 2019/6 and their Marketing Authorisation (MA) validity.

What is the main difference of these documents with regards to MA validity?

With regards to MA validity, the main difference between Directive 2001/82/EU and Regulation (EU) 2019/6 is the timeframe for MA validity. Directive 2001/82/EU limits the validity of MA for Veterinary Medicinal Products initially to five years, MA regulated under Regulation (EU) 2019/6 will have an unlimited validity (exceptions apply). Both documents clarify the provisions already contained in the applicable legislations. A new one-step process for acquiring an MA for VMPs for an unlimited duration will replace the previous two-step process.

Sample clarifications

For the Centralised Procedure (CP), MAHs with MA for VMP that expiry on or after 28/January/2022 will receive a letter from the EMA concerning the expiry date. With a positive reply from the MAH, the EMA will initiate steps to ensure unlimited validity of the MA. In the case of no (or a negative) reply, the MA will expire.

For the CP, MA submitted before 28/January/2022 but yet undecided will be dealt with under Directive 2001/82/EC.

What happens to MAs with validity after 28/January/2022 but with MA granted before 28/January/2022? As renewals should be submitted at least six months before the MA ceases, MAs will be handled according to Directive 2001/82/EC. In the case of the validity of the MA ending after 28/January/2022 with a submission date also falling after this date, no renewal application is required. The validity for the MA will be amended by the NCA.

In summary

With the New Veterinary Regulations now only months away, MAHs have to decide on when best to submit VMP renewals to make the most of the unlimited validity of MA under Regulation (EU) 2019/6. Replacing the two-step process under Directive 2001/82/EU with a one-step process under Regulation (EU) 2019/6 is certainly an improvement, but rules will apply. However, this is one final step to get to an unlimited validity of the Veterinary Medicinal Product more quickly….

FDA Guidance for Industry: Development of Abbreviated New Drug Applications during the COVID-19 Pandemic

In April 2021 the FDA released a new question & answer guidance document for the industry, specifically addressing Generics and their challenges during the COVID-19 pandemic. As the guidance is coming into effect immediately without prior public comments, it is worth having a closer look.

The FDA has issued this guidance to provide general recommendations to (prospective) applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions. The FDA has collated the questions and is presenting the responses in this guidance document for the benefit of all stakeholders. The FDA intends to revise/update this guidance as appropriate.

What does the guidance contain?

The guidance document has been structured into the following categories:

A) Generic drug product development;
B) Submission and assessment of ANDAs; and
C) Marketing and exclusivity.

Each category addresses different areas of concerns.

Category A: Generic drug product development

Questions in this category are mainly about bioequivalence studies and how any study interruption can be handled and whether multiple batches of reference products can be used in particular circumstances.

Category B: Submission and assessment of ANDAs

Questions in this category mainly address concerns about ANDA submissions for medicinal products that help with the COVID-19 public health emergency and possible site inspections that cannot take place because of restrictions invoked by the COVID-19 pandemic.

Category C: Marketing and exclusivity

Questions in this category address tentative drug approval and any impact of COVID-19 on timelines, specifically on exclusivity for Generics.

What other support is available for Generics?

Although not directly linked to the COVID-19 pandemic, the FDA has just launched the “Generic Drug Cluster” to improve global regulatory alignment among agencies, specifically in countries with focus on development of generic medicines. The “Generic Drug Cluster” aims to increase scientific alignment with the following objectives:

• Achieving a common understanding of each Agency’s regulatory requirements for approval and current thinking on topics related to generic drug development through information sharing on approval requirements and recommendations conveyed in guidance documents.
• Offering a confidential forum for exchange of discussion on policies in development, including draft guidances for industry, and the scientific basis for decisions on those policies.
• Provision of a forum for a discussion of general and product/class-related scientific review issues and fostering alignment in approaches to scientific evaluation whenever possible.
• Addressing long-term safety issues to ensure a global safety net for generic drugs through confidential sharing of reports.

Hopefully other agencies will also see a benefit in this forum to support global generic drug development.

In summary

With this Q&A guidance for industry, the FDA has addressed some of the questions faced by the Generics industry, in particular about the possible impact of the COVID-19 pandemic. The FDA provides some of the options available to the industry for handling studies and batches used to conduct bioequivalent studies as well as inspections. For Generics it will be a relief though that the FDA is not automatically rejecting applications that include sites that cannot be inspected because of COVID-19 restrictions. Approval decisions will be based on the entire information available. A key point is that marketing of a tentatively approved ANDA will not be possible.

With the recently launched “Generic Drug Cluster”, the FDA opened a communication forum for the world’s leading regulatory agencies to address generic drug development globally. Let’s hope that other agencies will also see a benefit in this forum and participate.

EMA’s new veterinary product information template

To be able to support the new veterinary regulations coming into effect in January 2022, the EMA updated the product information template that can be accessed here . The new template includes a new section on restrictions on the use of antimicrobials and antiparasitic veterinary products in an attempt to reduce resistance.

The other thing to notice is that the new template will address the need for Marketing Authorisation Holders (MAHs) to address any environmental issues. One notable example is the need to include information on special precautions for the protection of the environment – this information will help users of the medicinal product to better defend the environment.

What are the timelines?

One of the main aspects of the new template is that it supports the requirements under Regulation (EU) 2019/6, coming into effect 28/January/2022. Therefore, template version v9.0 should be used for all initial marketing applications after 28/January/2022. For product information of medicinal products placed on the market in accordance with Regulation (EC) 726/2004, template v8.2 may be used until 29/January/2027.

Please note that QRD template v.8.2 was revised in December 2021 to specify Northern Ireland as a local representative.

What does the new template v9.0 contain?

• a new structure of the SPC labelling and package leaflet with the order of sections aligned as far as possible;
• information only to be included in the package leaflet that was formerly in the labelling, simplifying the outer and immediate labelling;
• a consolidated section on ‘minimum particulars to appear on small immediate packaging units’ which now incorporates blisters and strips;
• a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary products. This includes restrictions on conditions of use that are not in accordance with the terms of the marketing authorisation (MA);
• expanded guidance text in many sections to improve clarity for applicants and regulators;
• standard text for “marketing authorisation” granted for veterinary limited markets and under exceptional circumstances;
• reference to national collection systems for disposal of waste veterinary medicines.;
• guidance on specific content for novel therapies;
• increased flexibility in some sections;
• consolidated section for all contact details.

EMA also simplified the SPC and package leaflet sections on ‘frequency and seriousness of adverse events’.

In summary

It is clear that a big effort has been made to align the QRD template with the NVR coming into effect in January 2022. Although we can expect finalisation of the combined label-leaflet QRD in the fourth quarter of 2021, companies can already align their data and processes with the new template v9.0.

EMA electronic Product Information (ePI) Consultation

Expert and public comments sought on ePI, open until 31/July/2021.

The EMA has opened a public consultation on the draft EU common standard for electronic product information or ePI. The consultation period is open until end of July 2021 so there is little time left to give feedback. Comments should be provided via an online form accessible here.

Consultation is sought on the following documents:

• ePI API (Application Programming Interface) specification and the associated ePI API service list;
• A FHIR (Fast Healthcare Interoperability Resources) XML (eXtensible Markup Language) template based on the QRD (Quality Review of Documents) template for human medicines.
• An instance of an ePI sample message is provided in XML and HTML (Hypertext Markup Language), along with a sample XSL (eXtensible Stylesheet Language) transformation.

All documents are available on GitHub here.

What is ePI?

EU Common Standard for electronic product information (ePI) is authorised, statutory product information for EU medicines including the summary of product characteristics or SmPC, labelling for outer and inner packing and the package leaflet in a semi-structured format. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print.

What is the ePI FHIR message template?

The objective of the ePI (FHIR) template is that it is to be used by template engines to transform PI information, in structured or semi-structured format to an ePI FHIR message.

Transformation of PI information (Source: EMA)

The resulting ePI XML message contains a FHIR resource, a Bundle of Bundles, each of which is a document having a composition, and supporting resources. The EMA will publish progress updates and details of stakeholder consultations and share these with patients, healthcare professionals, and the pharmaceutical industry.

Considerations on ePI

I believe it is important to state that the ePI initiative does not change the product information leaflet itself. It is merely a move away from a cumbersome paper-based system and an opportunity to streamline the processes of creating accurate product information leaflets on time in electronic format. The current mixture of structured and semi-structured data that we have seen in SPC documents for years does not support sophisticated data research and analysis. Maximum benefits of ePI would only be achieved via the use of electronic based package information leaflets. Updating or printing of the ever-changing leaflets would be a thing of the past, reducing the risk of having outdated package leaflets or even medicinal product recalls because of incorrect or outdated information. Professionals and the public would have instant access to the correct data online.

In summary

The ePI is well overdue, allowing the move away from outdated paper-based systems to modern electronic data management. With the envisaged use of FHIR for ePI, the path is set to modernise paper-based management of package leaflets. This more data driven approach is promising as long as it can be implemented European wide, not only at the EMA but also for national competent authorities. The benefits for professionals and the public include immediate access to the latest approved product information, availability of additional materials such as video and possible alerts informing about major leaflet updates.

The EMA has opened up a consultation period for professionals and the public alike to gather information on how best to support regulators, marketing authorisation holders, and the public using ePI, electronic product information. They need to know that the adopted Common Standard meets the needs of its future users, confirming they can access, view and disseminate product information in electronic format, ePI.

EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’

Action required: Pilot started 25/March/2021.

In March 2021 the European Commission, together with the EMA and Member States, committed to initiate a pilot to better understand the root causes of deferred market launches for centrally authorised products. The initiative has been launched with the engagement of future Marketing Authorisation Holders (MAHs).

The pilot’s overall objective is to “improve regulators’ knowledge of the planned marketing of centrally authorised medicinal products (CAPs) and on the reasons behind delayed market launch by engaging with prospective marketing authorisation holders through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorisation phase.”

Why are Marketing Authorisation Holders not launching medicinal products European wide?

MAHs are not obliged to market a medicine in all EU countries even though they have achieved approval under the Centralised Procedure (CP). The reasons could be many, for example

  • National pricing and reimbursement policies
  • Market size and hence market potential
  • Organisation of health system including distribution of medicinal products
  • Administration burden
  • Operational limitations
  • Therapeutic area and availability of specialised staff and/or infrastructure

Which products are eligible for the pilot?

It is envisaged that only certain medicinal products will take part in this pilot. These products are orphan and oncology medicines in the context of newly submitted centralised applications, as well as centralised applications under assessment. Products are identified by their link to unmet needs and high public interest.

What method will be used?

Any MAH can take part in this pilot. MAHs will supply information about planned market launch and rollout of the medicinal product. Reasons for not bringing products to market or delayed launches will help to analyse and understand any possible impact, on both the MAH and member states.

MAHs should provide the following information:

  • Identification of the marketing authorisation applicant;
  • Identification of the medicinal product and its active substance;
  • Member States in which the company intends to market the product;
  • The envisioned timing of market launch per country;
  • Remarks on market launch intentions.

Templates for MAHs to notify any ‘Market Launch Intentions’ are provided by the EMA.

It is planned to run this pilot for a period of 18 months, beginning 25/March/2021. If you wish to take part, details can be found on the European Commission website here.

In summary

The aim of the pilot is to get a better understand of why MAHs that pursue the centralised procedure choose not to market their products in all European Union countries. Upon completion of the pilot, the data gathered will be analysed to see whether the reasons mentioned above (if any) are the contributing factors. Results and lessons learnt from this pilot will be published by the European Commission.

Can our four-legged friends help us get out of the COVID-19 pandemic?

Dogs are well known for their abilities to sniff out drugs even when hidden in the most concealed containers. K-9s assist humans worldwide by supporting the visually disadvantaged, hearing impaired and diabetic patients and they are well known to many of us undertaking security checks on airports. In more recent years though dogs are also assisting patients with other life-threatening health conditions.

How can K-9 be so effective?

Dogs are lucky to have about 300 million olfactory receptors in their noses, compared to a mere six million in humans. Hence dogs will be able to sniff out far more than humans will ever be able to. Furthermore, the part of a dog’s brain that is responsible for analysing smells is about 40 times larger than in humans. With that in mind, it is no wonder that dogs are able to retrace their steps for days as many of our dog walkers can relate to. There is another thing though. Dogs also have something called neophilia, which means they are attracted to new and interesting odours. Another factor many owners are far too familiar with.

Another more unknown factor is that when humans exhale through their nose, the spent air comes out in the same way it came in. In contrast, when dogs exhale, the spent air exits through the slits in the sides of the nose. This basically means, that dogs can more or less sniff continuously.

All these factors make dogs prime targets to assist in medicine by sniffing.

Any chance of K-9 assisting with fighting the COVID-19 pandemic?

In the UK, ‘Medical Detection Dogs’ has many years of experience in training dogs to detect different kinds of odours of diseases. These “bio detection dogs” are trained in a controlled environment to detect the odour of disease from samples, and then to apply that knowledge to detect certain medical conditions.

Previous work in this area has been published in the Lancet Infectious Diseases, funded by the Bill and Melinda Gates Foundation. During an earlier study, dogs were able to detect the presence of malaria with an effectiveness of over 90%.

Against COVID-19, ‘Medical Detection Dogs’ undertook a small study to assess whether four legs and a wet nose are the next weapon. The, until 01/June/2021, unpublished study found that people that were infected with the COVID-19 virus give off a distinct odour, detectable by our K-9 friends. The most accurate sniffer dog achieved 94.3% sensitivity. Comparing that with 97.2% for PCR (Polymerase chain reaction) tests, an astonishing result.

Another initiative led by the ‘National Veterinary School of Alfort’ is in line with the findings from ‘Medical Detection Dogs’, i.e. that dogs excel in the detection of COVID-19. With an efficiency of 97% based on over 300 people tested, our K-9 friends are very effective in sniffing out the true positives of the virus.

What type of dog might be suitable?

Sighthounds such as deerhounds or greyhounds are probably not a good idea as they are more interested in ‘chasing’, especially moving targets. What is needed are gundogs such as labradors, retrievers or spaniels that are best suitable as their main desire is ‘searching’, less ‘chasing’.

In summary

With K-9s being special to many individuals, by supporting people affected by diabetes or other life-threatening conditions, their support in medicines seems to be just starting. Sniffing out COVID-19 is the latest achievement our four-legged friends can assist with. And with an accuracy of over 90% in detecting COVID-19 during two independent studies that is comparable to more invasive COVID-19 tests, opportunities for support during this pandemic seem endless. Being able to sniff out the virus in airports, train stations or major events in seconds rather than waiting for a more traditional PCR test is an advantage not to be underestimated. The veterinary sector just became another important factor in beating COVID-19.

Samarind RMS is already supporting many clients in the veterinary sector, including the New Veterinary Regulations coming into effect next year.

SPC harmonisation: Call for Contribution to the Public Consultation of the Best Practice Guides of the CMDv

Action required: Consultation period for ‘SPC harmonisation’ ends 29/June/2021.

The CMDv (Co-Ordination Group for Mutual Recognition and Decentralised Procedure – Veterinary) is seeking feedback on its Best Practice Guides (NPGs) related to the New Veterinary Regulation (NVR), coming into effect on 28/January/2022. The Best Practice Guides have either been newly created or are updated accordingly. If you would like to get further information about the NVR itself, please refer to a previous blog here.

The CMDv published the table below, containing a list of documents and deadlines for consultation.

Please note that the CMDv will update the list of available documents as and when appropriate.

As a reminder, the initial objectives of the Regulation (EU) 2019/6 should be taken into account when commenting on the Best Practice Guides. And here more specifically the objectives of reducing administrative burden, enhancing the functioning of the internal market, increasing availability and safeguarding public health, animal health, animal welfare and the environment.

These Best Practice Guides have been prepared by the CMDv to be used during the SPC harmonisation procedures by Reference Member States (RMS), Concerned Member States (CMS) as well as the marketing authorisation holders (MAH), in order to facilitate the SPC harmonisation procedure.

What are the Harmonisation Procedure phases?

The SPC harmonisation procedure for veterinary medicinal products (VMP) can be divided into three phases:

1. Selection phase; MAH as well as Member States (MS) can suggest products to be considered.
2.A Examination phase for the reference veterinary medicinal product; determination whether the acceptance criteria to be eligible for the harmonisation procedure have been met.
2.B National phase for updating the SPC of the reference veterinary medicinal product.
3.A Harmonisation of the SPCs of generic and hybrid veterinary medicinal products.
3.B National phase for updating the SPCs of the generic and hybrid veterinary medicinal products.

According to these procedures National Competent Authorities (NCA) as well as MAHs may propose harmonisation of the SPCs of Reference Veterinary Medicinal Products (RVMPs) for which a marketing authorisation has already been granted.

A number of criteria for the prioritisation of the SPC harmonisation have been identified. However, it is probably disappointing that taking resource limitations within the agency network into account combined with untried and untested procedures, it is estimated that during the first year of implementation only 5-6 veterinary products can be short listed.

What is the impact of the SPC harmonisation on MAHs?

For products that are shortlisted by the CMDv, the CMDv working group on SPC harmonisation will first identify all MAHs with MA from the Union Product Database (UPD). VMPs should have the same active substance as those of the reference VMP. Targeted requests will be sent to MAHs concerned to provide information on the link between the MA of their product and the products identified on the CMDv shortlist.

For the reference VMPs listed in the CMDv shortlist for which the proposal for SPC harmonisation was not made by the MAH themselves, the MAH will be requested to provide the following information on their reference VMPs:

  • List of countries where the reference VMP is authorised;
  • Product name(s) and name and address of the MAH in all the countries where the reference VMP is authorised;
  • Type of marketing authorisation procedure in each of the MS where the reference VMP is authorised;
  • MRP number (if applicable);
  • MAH contact point for the SPC harmonisation (name, email and telephone number).

MSs might ask for additional information in case – for example – drug safety might be affected.

Comparative table to be submitted by the MAH

The CMDv provides further assistance (shown in the sample table below) to MAHs with regards to the information that should be provided in case the MAH (for each MS) makes a request to shortlist a reference VMP for the SPC harmonisation procedure.

Additional templates for requests are also provided. Users of the Samarind RMS solution have this information available at their fingertips, minimising time and effort spent to collect the right information from multiple sources accurately.

In summary

The Best Practice Guidance documents provide a good overview of the process to be adapted for the new SPC harmonisation procedure. Further details describe what MAH and NCA can expect and should provide. The provision of templates will simplify the process, but if you have a solution such as Samarind RMS, the information is already available at your fingertips.

Please keep in mind that the consultation deadline is 29/June/2021 if you wish to share your thoughts on the proposed SPC harmonisation guides.