Market Access
Market access refers to the ability for a firm to purchase and sell goods or services in one or more markets. It is a critical element in any company’s business strategy, as it has the potential to open up new opportunities and spark a range of customer relationships. Understanding the different aspects of market access is essential for any business looking to succeed in their chosen markets.
In this article, we will take a closer look at market access and registration, as well as the implications of these for businesses.
Research markets
When looking to enter a new market, it’s important to do your research and gain an in-depth understanding of the size, nature and potential of that market. This will give you an indication of the level of success you may be able to achieve and help guide your decision-making when considering a move into the new market.
Gathering relevant government data on market trends can be beneficial. Your research should include applying for industry reports, where they are available, as well as exploring similar companies operating in that space. Examining the logistical challenges associated with selling into the region and gauging local sentiment around foreign investment are also useful steps in making an informed decision.
In addition to researching established markets, investigate emerging ones as well—new markets may offer tremendous opportunities for growth and lack significant competition. Additionally, take into account resources which may assist your journey such as incubators or accelerator programs which provide support for small businesses embarking on international expansion. Overall careful planning and research is key for successful market access.
Understand relevant regulations
For any product to be marketed in the marketplace, it is essential to understand and adhere to the relevant regulations governing its registration. In order to ensure compliance and acceptance in all markets, most companies go through a registration process that involves ensuring that the product meets all necessary national laws, regulations as well as any applicable international standards.
To acquire a full understanding of the applicable market access requirements, companies should consider researching relevant national laws and regulations, including labelling requirements for product quality assurance; exploring potential certification of their product by third-party organizations; staying up-to-date on potential changes or updates in market regulations; conducting due diligence on local partners or representatives; assessing country-specific health and safety requirements for operation; and consulting with experts on specific market access issues within each regional jurisdiction.
By carrying out comprehensive pre-market research into all regulatory aspects of a region’s specific jurisdiction(s), companies can minimize risks associated with market entry, optimize time spent on regulatory processes, avoid costly mistakes and hasten overall success in new markets.
Determine the appropriate registration process
In order to access a certain market, companies must determine which regulatory and registration process is appropriate for their products. Depending on the target market and product type, companies should consider three main steps in the registration process: (1) create a dossier of technical specifications; (2) gain authorization to export within a specific jurisdiction; and (3) comply with labelling requirements.
The creation of a product dossier is the first step in obtaining authorization to export within a given jurisdiction. It typically contains detailed information about the physical characteristics of the product, including chemical composition, quality specifications and manufacturing processes. The dossier must also provide evidence that the relevant safety requirements have been met and that proper quality control procedures are in place.
The next step is gaining authorization to export products into a specific jurisdiction. To do so, manufacturers must apply for approval from the relevant country before launching their products or entering into agreements with local distributors. This typically involves providing copies of all necessary documentation relating to manufacturing processes and obtaining certification from local laboratories or through mutual recognition agreements for products that have already been approved by another jurisdiction.
Finally, manufacturers need to ensure that their products meet any applicable labelling requirements in their target countries/regions before they can be marketed abroad. Often these require labels reflecting specific composition claims or even mandatory national language versions of labels being used elsewhere throughout the world – both in terms of content at label size/formatting – so it important that companies familiarize themselves with these unique expectations ahead of time.
Registration Process
Registering and accessing a market can be a complex process with many different steps and regulations to follow. To make it easier to understand, we’ll look into the registration process in detail.
We’ll discuss the different steps necessary to gain access to a market and the regulations that need to be taken into consideration.
Collect and submit required documents
Prior to submitting the registration application, it is important to ensure that all the required documents have been collected and prepared. Depending on the product type, industries and market requirements, various documents such as product certificate of compliance, safety documents, health certificates, manufacturing and market authorization certificates, compendial or non-compendial evidence of good manufacturing practices etc. may be needed for registration purposes. Therefore, it is best to review respective industry regulation, check with local authorities or contact consulting organization when in doubt regarding the specific regulatory requirements pertaining to the document collection.
Some of these documents may require notarization or legalisation depending on country specific requirements. It is important to understand if an official government agency seal or signature needs to be affixed before preparation/submission of the documents related to registration application at each local market. The type of certification and number of physically signed copies required often differ from country-to-country therefore should be taken into consideration while collecting necessary documentation for a successful registration process.
Obtain necessary certifications
In order to access markets, you need to make sure that the necessary certifications are obtained and maintained. Depending on the type of product and the target market, there may be several certifications that are required. To understand which certificates are needed and how they are obtained, it is important to consult reliable sources such as government websites or relevant bodies in the field.
For some products, there may be local-level certifications that need to be obtained in addition to global requirements such as a ISO standard. In addition, private certification bodies may require that your product meets their standards for quality and safety for you to be accepted into their certification program.
Each certificate comes with its own language requirements and protocols regarding use of the certificate mark — including where and how it’s used on packaging material or promotional materials. It is important to understand all aspects of these protocols in order to avoid any potential infringement issues. Once all necessary documentation has been collected, properly filled out versions should be kept on file as proof of certification when they are requested by various regulatory authorities or buyers at home or abroad.
Pay registration fees
The next step in the registration process is to submit payments of all applicable registration fees. This is important as these fees are what allows the government to issue newly registered market participants the necessary licenses, permits, and documents needed to obtain access to the market. Depending on which country and activity you wish to register for, the fees may vary. It is crucial to do your research in order to save time and money.
Once payment is received, your application will be reviewed by a legal or administrative governmental department or agency for final approval. All necessary documents will be issued upon clearance of this review process. Once documents have been issued you may begin operation in the selected market accordingly.
It is important that prospective businesses allot sufficient lead time for this part of the registration process in order to ensure that their operations can begin as quickly as possible without any unnecessary delays in associated market access requirements and paperwork processing times.
Post-Registration
Post-registration is an important step in gaining market access and is necessary to enable the marketing of a product in certain countries or regions.
It involves the post-registration activities such as the regularization of product labelling, the update of information, the receipt of the marketing authorization, and the maintenance of the compliance with the local legislation.
The post-registration activities should be performed in accordance with the local regulations in order to ensure the compliance with the local laws.
Monitor registration status
Market access and registration is a complex environment and there are many regulatory bodies in different countries across the globe. It is vital to stay informed, knowledgeable and compliant with local regulations to remain competitive.
Companies need to regularly monitor their country registrations by keeping track of the changes in laws, assess new regulations or guidelines issued by various local authorities. In addition, ensuring that product applications have been properly submitted, processed and approved according to local legal requirements remains a critical factor for any company seeking market access into a new country.
To stay up to date on registration status, companies should consider exploring options such as:
- Reading up on recent news and blogs relevant to market access;
- Retaining the services of an expert consultant;
- Subscribing to trade reports related to specific markets;
- Joining professional networks and attending regional industry meetings;
- Monitoring local media outlets and regulatory bulletins where available.
By staying in tune with all relevant news sources, companies can know when it is time for renewal of registration or when any sudden changes occur in the registration process which may impact compliance within different markets and jurisdictions. Adapting a regular monitoring process provides significant benefits over relying solely on ad hoc inquiries or manual checks – improving timeliness of information as well as overall accuracy of the data collected.
Ensure compliance with regulations
A post-registration phase includes activities that must be conducted to protect the product and maintain compliance with relevant regulations. Depending on the product, these activities may include:
-Developing, implementing and regularly reviewing a continual Quality Assurance (QA) management system for the duration of the product’s lifecycle.
-Ensuring all necessary documents are updated as required and stored securely in accordance with regulations
-Meeting reporting requirements including post marketing surveillance and vigilance as defined by applicable regulations
-Staying up to date with changing regulations in areas such as ingredient composition, labelling, shelf life parameters and packaging specifications relevant to the product
-Managing regulatory inquiries such as queries related to safety and efficacy of ingredients or formulation changes.
Update registration information as needed
Periodic updates of registration information are necessary after a product is initially registered. Regulatory changes, whether driven by industry needs or evolving business needs, mean that the company must be vigilant in keeping the registration current. This might take the form of changing labelling language, updating the formula with an improved ingredient list, or changing a description or picture to illustrate continuously improving product chemistry or formulation.
Companies should become familiar with both regional and international requirements for products and must anticipate when regional government and other guidelines will change due to specific economic drivers and market factors. Companies that wish to maintain market access must be on guard for changes to laws, regulations and policies affecting product registration so that their products ever remain compliant with stated requirements. Such vigilance is particularly important when selling products in multiple countries across various regions.
It is also important for manufacturers who do not anticipate any changes in their product formulation to review local regulatory guidelines on a regular basis as it is possible hidden amendments may go unobserved over time if no review takes place. Additionally, it’s essential to note any shelf-life expiry dates taking into consideration licensing expiration dates as even an expired license can lead to drastic revenues losses if unmonitored or unchallenged keeping in mind your usual delivery schedules and duties performed by agents, distributors etc related to it. Finally, manufacturers should also take into consideration local stakeholder feedback including consumer preferences as well as competitive insights from retailers so that products can remain competitive within their marketplace accordingly.
